Refractory Epithelial Ovarian Cancer Research Articles

A phase II clinical trial with proteomic profiling of imatinib mesylate in patients with refractory or relapsed epithelial ovarian cancer (EOC)

9651 Background: PDGFR-β and c-kit expression have been described in EOC and imatinib is an inhibitor of both. A phase II clinical trial with proteomic signal pathway profiling is underway to elucidate both the clinical and biological activity of this new agent in EOC. Methods: Patients with relapsed or refractory EOC and no more than 4 prior regimens received imatinib at 400 mg bid; the starting dose was lowered to 600 mg daily due to toxicity. Patients were treated continuously in 28 day cycles and examined every 4 weeks, with imaging every 8 weeks. Tumors were biopsied prior to and after 4 weeks of treatment. Cytokine and growth factor concentrations were measured by ELISA in plasma and fluid samples. Results: Sixteen patients with a median of 4 prior regimens have been enrolled with 15 evaluable. Seven patients (47%) started treatment at 400 mg bid; 4 withdrew within 1 month. The remainder (9) started at 600 mg qd. Five patients (33%) without evidence of disease progression experienced unacceptable to...

A phase II clinical trial with proteomic profiling of imatinib mesylate in patients with refractory or relapsed epithelial ovarian cancer (EOC)

9651 Background: PDGFR-β and c-kit expression have been described in EOC and imatinib is an inhibitor of both. A phase II clinical trial with proteomic signal pathway profiling is underway to elucidate both the clinical and biological activity of this new agent in EOC. Methods: Patients with relapsed or refractory EOC and no more than 4 prior regimens received imatinib at 400 mg bid; the starting dose was lowered to 600 mg daily due to toxicity. Patients were treated continuously in 28 day cycles and examined every 4 weeks, with imaging every 8 weeks. Tumors were biopsied prior to and after 4 weeks of treatment. Cytokine and growth factor concentrations were measured by ELISA in plasma and fluid samples. Results: Sixteen patients with a median of 4 prior regimens have been enrolled with 15 evaluable. Seven patients (47%) started treatment at 400 mg bid; 4 withdrew within 1 month. The remainder (9) started at 600 mg qd. Five patients (33%) without evidence of disease progression experienced unacceptable toxicities. Eleven patients (73%) experienced grade 3/4 toxicities. Fluid related toxicities included the following events: ascites 40% (6/15), pleural effusion 27% (4/15), and/or peripheral edema 13% (2/15). Non-fluid related grade 3 toxicities included nausea 27% (4/15), vomiting 20% (3/15), constipation, anorexia, hypoalbuminemia, anemia, and leucopenia (1 each); Median time on study was 63 days. Disease stabilization was observed for 4 and 5 months in 2 patients, respectively. Plasma VEGF and PDGF-AB increases were greater in patients who developed symptomatic ascites (p= 0.0012 and 0.04, respectively). Ascites reversed with cessation of imatinib. Profiling by tumor lysate arrays of proliferation, survival, and angiogenesis signaling pathways in tumor and stroma, and a potential mechanism for imatinib-related ascites accumulation will be presented. Conclusions: Imatinib has significant fluid related toxicity in patients with EOC precluding assessment of clear benefit. Based on this data there may be potential benefits from combination therapy with angiogenesis inhibitors. No significant financial relationships to disclose.

Phase I/II study of a docetaxel (DOC) and gemcitabine (GEM) combination for early recurrent (≤12 months)(ER) or refractory (R) epithelial ovarian cancer (EOC): Kansai Clinical Oncology Group, Japan

5046 Background:There is no standard chemotherapy regimen for EOC that does not respond to platinum-based chemotherapy (R-EOC), or responds but progresses within 12 months after completing chemotherapy (ER-EOC). Purpose: To determine the efficacy of a DOC and GEM combination for R-EOC or ER-EOC, we conducted phase 1/2 study. Methods:Between October 2000 and November 2003, R-EOC or ER-EOC patients (pts) entered this multi-institutional study. Eligible criteria: histologically verified EOC, age 16 -75 years, ECOG-PS ≤2, adequate bone marrow, hepatic, and renal function, and written informed consent. GEM was administered on days 1 and 8, and DOC on day 8. This treatment was repeated every 3 weeks. The doses were escalated as follows: dose level 1 (DL1); DOC 70 mg/m2, GEM 800 mg/m2, DL2: DOC 70 mg/m2, GEM 1000 mg/m2. Toxicities were assessed according to NCI-CTC ver2.0J and responses were assessed according to both RECIST for measurable disease and Rustin's criteria for CA125. Results:Thirty-four pts were enrolled and administered 95 cycles. The median cycle was 3 (1–7 cycles), median age was 56 years (21 to 74 years), and median interval from prior chemotherapy was 2 months (1 to 12 months). Seventeen pts received more than 3 chemotherapy regimens before the enrollment. Three pts experienced no dose-limiting toxicities (DLTs) in DL1. Two of the three pts in DL2 were experienced DLTs: febrile neutropenia grade 3 (1), and thrombocytopenia grade 4 (1). Then, 28 patients were subjected to the phase 2 study with DL1 as a recommended dose. Thirty-two patients were assessable for response. Response rate was 19.1% (6/32) with 1CR (3.1%), 5PR (16%), and 9SD(28%). One-year and 2-year survival were 51.2% and 23.4%, respectively. The median survival time was 13 months. Toxicities were mainly hematological (G3/G4): neutropenia (16%/50%), thrombocytopenia (19%/0%), anemia (13%/0%), and febrile neutropenia (3%/0%). There were no grade 3 or 4 non-hematological toxicities. Conclusions:A DOC and GEM combination for R-EOC and ER-EOC with DL1 is active and well tolerable. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly Japan K.K.

Phase I/II study of a docetaxel (DOC) and gemcitabine (GEM) combination for early recurrent (≤12 months)(ER) or refractory (R) epithelial ovarian cancer (EOC): Kansai Clinical Oncology Group, Japan

5046 Background:There is no standard chemotherapy regimen for EOC that does not respond to platinum-based chemotherapy (R-EOC), or responds but progresses within 12 months after completing chemotherapy (ER-EOC). Purpose: To determine the efficacy of a DOC and GEM combination for R-EOC or ER-EOC, we conducted phase 1/2 study. Methods:Between October 2000 and November 2003, R-EOC or ER-EOC patients (pts) entered this multi-institutional study. Eligible criteria: histologically verified EOC, age 16 -75 years, ECOG-PS ≤2, adequate bone marrow, hepatic, and renal function, and written informed consent. GEM was administered on days 1 and 8, and DOC on day 8. This treatment was repeated every 3 weeks. The doses were escalated as follows: dose level 1 (DL1); DOC 70 mg/m2, GEM 800 mg/m2, DL2: DOC 70 mg/m2, GEM 1000 mg/m2. Toxicities were assessed according to NCI-CTC ver2.0J and responses were assessed according to both RECIST for measurable disease and Rustin's criteria for CA125. Results:Thirty-four pts were enrolled and administered 95 cycles. The median cycle was 3 (1–7 cycles), median age was 56 years (21 to 74 years), and median interval from prior chemotherapy was 2 months (1 to 12 months). Seventeen pts received more than 3 chemotherapy regimens before the enrollment. Three pts experienced no dose-limiting toxicities (DLTs) in DL1. Two of the three pts in DL2 were experienced DLTs: febrile neutropenia grade 3 (1), and thrombocytopenia grade 4 (1). Then, 28 patients were subjected to the phase 2 study with DL1 as a recommended dose. Thirty-two patients were assessable for response. Response rate was 19.1% (6/32) with 1CR (3.1%), 5PR (16%), and 9SD(28%). One-year and 2-year survival were 51.2% and 23.4%, respectively. The median survival time was 13 months. Toxicities were mainly hematological (G3/G4): neutropenia (16%/50%), thrombocytopenia (19%/0%), anemia (13%/0%), and febrile neutropenia (3%/0%). There were no grade 3 or 4 non-hematological toxicities. Conclusions:A DOC and GEM combination for R-EOC and ER-EOC with DL1 is active and well tolerable. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly Japan K.K.

Evaluation of Recombinant Human Interleukin-12 in Patients with Recurrent or Refractory Ovarian Cancer: A Gynecologic Oncology Group Study

Objective. The goal of this study was to estimate the antitumor activity and toxicity of recombinant human interleukin-12 (rhIL-12) in patients with recurrent or refractory epithelial ovarian cancer.Methods. From December 1997 to March 1999, patients with recurrent or refractory epithelial ovarian cancer were entered on a Gynecologic Oncology Group phase II study of intravenous rhIL-12. All patients had measurable disease, had a performance status of 0–2, and had failed first-line platinum-based chemotherapy regimen. Eligible patients received rhIL-12, 250 ng/kg IV bolus, as a single dose on Day 1 followed by a 2-week rest period, with subsequent cycles administered daily for 5 days followed by a 16-day rest period per cycle, until disease progression or adverse effects prohibited further therapy.Results. Twenty-eight patients were entered and evaluable for toxicity, while 26 were evaluable for response. The median age was 59.5 years (range: 45–77). The median number of cycles was 2 (range: 1–9). There were no complete responders; however, one patient (3.8%) was a partial responder and 13 patients (50%) had stable disease. Grade 4 myelotoxicity occurred in 21% of patients. Two patients experienced capillary leak syndrome: one grade 2 and one grade 4.Conclusion. As a single agent, rhIL-12 is tolerable and shows a low response rate in recurrent epithelial cancer with measurable disease.

An open label evaluation of topotecan in patients with relapsed or refractory epithelial ovarian cancer - single institution experience in a developing country.

Investigators in developing countries rarely get an opportunity to participate in clinical drug trials in oncology. We recently participated in two clinical trials involving the use of topotecan in patients with advanced epithelial ovarian cancer who had failed initial platinum based chemotherapy. It provided us an opportunity to gain experience with the use of a rather highly myelosuppressive drug and also enabled us to compare our data with those reported from the western countries. Thirty-nine patients with good performance status and adequate bone marrow, liver, and renal functions were accrued. All patients had previously received at least one platin containing regimen of chemotherapy. The most common histologic sub type was serous adenocarcinoma. Almost half of the patients had platinum refractory disease. Mean number of cycles delivered was 7.5. Eleven patients (28%) achieved complete or partial remission. Time to progression was 4.6 months. Mean overall survival was 11.3 months. Toxicity was primarily hematologic and manageable. Performance status was the only variable predictive of response. Ability to obtain informed consent, data management, and availability of adequate radiologic and laboratory facilities were important limitations. Our results confirm the applicability of results obtained in the western countries to other patient groups and ability to conduct clinical trials in oncology in the developing countries.

Phase II Study of Liposomal Doxorubicin in Platinum- and Paclitaxel-Refractory Epithelial Ovarian Cancer

Stealth liposomal doxorubicin (Alzal Corp, Palo Alto, CA) has a slower clearance rate than free doxorubicin, resulting in sustained serum levels. Liposomal encapsulation also leads to increased concentration of drug in tumor tissue. Meta-analysis of previous studies has shown that doxorubicin has activity in epithelial ovarian cancer. The current study was developed to examine the activity of Stealth liposomal doxorubicin in platinum- and paclitaxel-refractory ovarian cancer. Patients had epithelial ovarian cancer that either progressed on or recurred within 6 months of completion of platinum and paclitaxel chemotherapy. All patients had measurable disease. Stealth liposomal doxorubicin was administered at 50 mg/m(2) every 4 weeks as a 1-hour infusion. Eighty-nine patients were treated and included in an intent-to-treat analysis. There were 82 patients who were platinum and paclitaxel refractory and met all study criteria. There was one complete response and 14 partial responses, for a total response rate of 16.9% (95% confidence interval [CI], 9.1% to 24.6%). For platinum- and paclitaxel-refractory patients, the response rate was 18.3% (95% CI, 9.9% to 26.7%). Median time to progression was 19. 3 weeks for the entire population. Ten patients (11.2%) withdrew because of adverse events related to the drug (palmar-plantar erythrodysesthesia [PPE], n = 3; asthenia, n = 2; cardiac, n = 2; neutropenia, n = 1; stomatitis, n = 1; and edema, n = 1). There were no drug-related fatal events. There were only eight grade 4 adverse events attributable to the drug. Stomatitis, PPE, and skin lesions were managed with dose reductions and delays in most cases. Stealth liposomal doxorubicin has activity in refractory epithelial ovarian cancer. PPE and stomatitis can usually be managed by dose adjustment. The ease of administration makes this an attractive agent.

A Phase I Study of a Daily ×3 Schedule of Intravenous Vinorelbine for Refractory Epithelial Ovarian Cancer

Purpose.To determine the toxicity and activity of intravenous vinorelbine given daily for 3 consecutive days every 3 weeks in patients with platinum-resistant epithelial ovarian cancer.Patients and methods.Between September 1994 and October 1995, 23 women with refractory epithelial ovarian cancer were entered onto this phase I study. All patients had measurable disease and platinum-resistant tumor, and prior therapy was limited to a maximum of two prior regimens. Nineteen (83%) were assessable for toxicity and 20 (87%) were assessable for response. Vinorelbine was administered intravenously daily for 3 consecutive days; this was repeated every 21 days. The starting dose was 20 mg/m2daily ×3, with dose escalation by 5 mg/m2daily ×3. Dose-limiting toxicity (DLT) was defined as grade 4 granulocytopenia for >3 days, grade 4 thrombocytopenia, neutropenic fever, or grade 3 or greater nonhematologic toxicity. The maximal tolerated dose (MTD) was defined as the highest dose level at which <50% of patients developed a DLT. Once the MTD of vinorelbine without granulocyte colony-stimulating factor (filgrastim) support was defined, dosing was begun at the MTD level and administration of 5 μg/kg filgrastim was initiated on day 4 and continued until WBC counts reached >10,000/μL. Clinical response, progression-free survival, and survival were also determined.Results.Nineteen patients evaluable for toxicity received a total of 135 cycles of vinorelbine. The major DLT was neutropenia. The MTD of vinorelbine without filgrastim support was established as 20 mg/m2daily ×3. The MTD of vinorelbine with filgrastim support was established as 25 mg/m2daily ×3. Of 20 patients evaluable for response, 2 patients (10%) had a complete response and 4 (20%) had a partial response, for an overall response rate of 30%.Conclusion.These results warrant further study of vinorelbine in patients with platinum-resistant epithelial ovarian cancer. However, further study of the daily ×3 schedule may not be warranted because of failure to achieve higher weekly dose intensity and because of nonhematologic toxicity in the form of intense bone pain.

Phase II study of 96-hr continuous-infusion etoposide and doxorubicin with bolus cyclophosphamide in refractory epithelial ovarian cancer: Fleming G.F.; Waggoner S.E.; Rotmensch J.; Skoog L.A.; Langhauser C. USA Gynecol Oncol 1997 65/1 (42–45)

International Journal of Gynecology & ObstetricsVolume 59, Issue 1 p. 92-92 Citations from the literature oncology Phase II study of 96-hr continuous-infusion etoposide and doxorubicin with bolus cyclophosphamide in refractory epithelial ovarian cancer Fleming G.F.; Waggoner S.E.; Rotmensch J.; Skoog L.A.; Langhauser C. USA Gynecol Oncol 1997 65/1 (42–45) First published: 11 May 2004 https://doi.org/10.1016/S0020-7292(97)90186-7AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume59, Issue1October 1997Pages 92-92 RelatedInformation

Phase II Study of 96-hr Continuous-Infusion Etoposide and Doxorubicin with Bolus Cyclophosphamide in Refractory Epithelial Ovarian Cancer

Effective salvage chemotherapy for patients with ovarian cancer who have failed platinum- and taxane-based regimens has not been identified. It has been reported that prolonged infusions of chemotherapy may be active in some malignancies which have become refractory to bolus treatments. We evaluated a regimen of 96-hr continuous-infusion doxorubicin (10 mg/m2/24 hr), etoposide (50 mg/m2/24 hr), and bolus cyclophosphamide (750 mg/m2) administered every 21 days to patients with ovarian cancer who had previously been treated with paclitaxel and a platinum compound. Nineteen women were treated, 15 of whom had platinum-refractory cancer. Six of the first 9 experienced a neutropenic fever after the first treatment cycle, and therefore all subsequent patients received prophylactic granulocyte-colony-stimulating factor. Other significant toxicities included hand and foot syndrome (1 patient) and mucositis (4 patients). There was one partial response in a patient with platinum-sensitive disease. We conclude that this regimen causes significant myelosuppression and does not have major activity in heavily pretreated patients with ovarian cancer.

Paclitaxel (Taxol) in relapsed and refractory ovarian cancer: the UK and Eire experience

The purpose of our study was to investigate the efficacy and toxicity of paclitaxel in patients with relapsed or refractory epithelial ovarian cancer in the context of a large multicentre study performed in the UK and Eire. Patients with previously treated epithelial carcinoma of the ovary or fallopian tube who fulfilled the eligibility criteria were entered in the study. Eligibility criteria included: measurable or evaluable disease; Eastern Cooperative Oncology Group (ECOG) performance status 0-2; up to three prior chemotherapy regimens, one of which had to contain a platinum agent; adequate haematological, renal and hepatic function; and no significant cardiac history. Patients received either 175 mg m-2 or 135 mg m-2 paclitaxel. The lower dose was administered to patients who had received more than two prior chemotherapy regimens. Paclitaxel was given by i.v. infusion over 3 h every 21 days. Response was assessed at three-cycle intervals or earlier if required. A total of 155 patients were registered for the study in the UK of whom 140 were eligible for response and toxicity evaluation, and 12 patients were assessed for toxicity only. Hair loss was the most frequently reported toxicity, with 74% (119/152) of patients reporting grade 3 alopecia. The most frequently reported serious toxicity was neutropenia, with 49% (74/152) of patients experiencing neutropenia grade 3 or 4. The response rate was 16% [two complete responders (CR), 20 partial responders (PR)], the median duration of response was 275 days and median survival was 244 days. Paclitaxel is active in relapsed and platinum-resistant epithelial ovarian cancer. It is well tolerated and can be given in an out-patient setting. The UK and Eire experience is very similar to that of US investigators in this group of patients. Further work is required to assess the optimal use of the drug in both first- and second-line therapy.

Primary Central Nervous System Recurrence after Paclitaxel Therapy for Epithelial Ovarian Malignancy

Paclitaxel is currently being utilized to treat neoplasms which have a significant incidence of central nervous system metastases. It is, however, unclear as to whether paclitaxel crosses the blood-brain barrier. In this report, the authors describe a patient with refractory epithelial ovarian cancer treated with paclitaxel at 135 mg/m 2/24 hr every 21 days. The patient achieved a complete clinical response of all abdominal and pelvic disease, but simultaneously developed central nervous system metastases. Paclitaxel was effective against the patient's abdominal and pelvic disease but was not protective against central nervous system metastasis.

Intraperitoneal radioimmunotherapy of refractory ovarian carcinoma utilizing iodine-131-labeled monoclonal antibody OC125

Refractory epithelial ovarian cancer is generally confined to the peritoneal cavity and is thus amenable to intraperitoneal (ip) therapy. Radiolabeled monoclonal antibodies raised to tumorassociated antigens offer the promise of selective tumor irradiation while reducing toxicity to normal tissues. We have conducted a phase I therapeutic trial to examine the feasibility of ip radioimmunotherapy utilizing escalating doses of 131I-labeled OC125 F(ab′) 2. Twenty-nine patients were each treated with a single dose of radiolabeled antibody. Twenty-eight patients were evaluable for dose-related toxicity. The toxicities most frequently observed were hematologic and gastrointestinal. Hematologic toxicity was noted in 5 14 (36%) patients receiving 18–87 mCi and in 12 14 (71%) receiving 100–144 mCi ( P = 0.018). The median white blood cell nadir of 2–3K/μl (range, 1.4–3.5K/μl) occurred at a median of 4.5 weeks and the median platelet nadir of 41K/μl (range, 20–78K/μl) at a median of 6.5 weeks. Mild gastrointestinal toxicity was observed in 4 14 patients (28%) at doses < 100 mCi whereas at doses ⩾ 100 mCi, 11 14 (79%) patients developed nausea, vomiting, or chronic ileus ( P = 0.021). This toxicity occurred most frequently in patients with protracted urinary 131I excretion. We conclude that 131I-labeled OC125 can be safely administered ip. Hematologic and gastrointestinal toxicity is predictable and related to the dose and rate of clearance of isotope.

Goserelin a GnRH-analogue as third-line therapy of refractory epithelial ovarian cancer.

Between October 1988 and March 1991, 23 ovarian cancer patients with progressive disease whilst receiving second- or third-line polychemotherapy received subcutaneously 3.6 mg Goserelin, a GnRH analogue, at monthly intervals until further tumor progression. Four patients (17.4%) achieved partial response, 7 patients (30.4%) had stable disease and 12 patients (52.2%) showed further tumor progression. Median time to tumor progression was 8.5, 5.3 and 2.1 months, respectively (Mantel test, P = 0.0003). Ten out of 11 patients who showed partial response or no change had grade 2 or grade 3 tumors. We conclude that Goserelin shows evidence of antitumor activity also in grade 2 and grade 3 ovarian carcinoma. It offers a therapeutic alternative to a group of patients, in whom we usually terminate cytotoxic treatment.

Leuprolide acetate in the treatment of refractory or persistent epithelial ovarian cancer.

Leuprolide acetate (Lupron, TAP Pharmaceuticals, North Chicago), a gonadotropin-releasing hormone analogue, was administered subcutaneously at a 1-mg dose for a minimum of 8 weeks to 23 patients with refractory epithelial ovarian cancer. Eighteen of these patients were evaluable. There were no complete responses. Four patients (17%) had a partial response, with a median duration of 52 weeks. Three of six patients with grade 1 carcinomas had a partial response and two had stabilized disease. There was only one response among 15 patients with grade 2 or 3 disease. Therapy was well tolerated, with three patients complaining of hot flashes and two of mild pedal edema. Leuprolide acetate thus shows evidence of antitumor activity against refractory grade 1 epithelial adenocarcinoma of the ovary. Further trials with larger numbers of patients should be conducted.

High-dose carboplatin with diethyldithiocarbamate chemoprotection in treatment of women with relapsed ovarian cancer.

Diethyldithiocarbamate (DDTC) has been found to protect the bone marrow, kidneys, and gastrointestinal tract from the toxic effects of cisplatin and carboplatin (CBDCA) in animal models. In an attempt to minimize the toxic effects of high-dose CBDCA (800 mg/m2), a pilot study was undertaken in which women with relapsed or refractory epithelial ovarian cancer were treated with high-dose CBDCA, which was followed 3 hours later with DDTC (4 g/m2). There were four partial responses and no complete response in 21 patients who could be evaluated (overall response rate, 19%). Significant toxic effects, including three treatment-related deaths, were associated with the regimen. This study suggests that while high-dose CBDCA plus DDTC may be active in relapsed or refractory ovarian cancer, it is associated with clinically significant hematologic and autonomic toxic effects.

A phase II trial of 4-demethoxydaunorubicin in refractory epithelial ovarian cancer

Sixteen evaluable patients with refractory epithelial ovarian cancer were treated with oral 4-demethoxydaunorubicin. The drug was given in divided doses over 5 days and dosage was repeated every 3 weeks. There were no objective remissions. Three patients had stabilized disease of 5 to 7 months duration. Although well tolerated, this anthracycline has modest effectiveness against previously treated ovarian cancer.

A phase II trial of bisantrene (CL216,942) in refractory epithelial ovarian cancer

Twenty-three evaluable patients with refractory epithelial ovarian cancer were treated with bisantrene (CL216,942). The drug was given as a single-dose injection every 3 weeks. One patient (4%) showed a partial response. The compound thus has limited activity against this malignancy.

Intraperitoneal cis-platinum as salvage therapy for refractory epithelial ovarian cancer

Eighteen patients with residual epithelial ovarian cancer at second-look laparotomy were treated with a combined total of 210 cycles of intraperitoneal cis-platinum. Sixteen patients had previously received cis-platinum containing combination chemotherapy systemically. Seven patients had microscopic residual disease at the start of intraperitoneal therapy, eight had macroscopic disease of 5 mm in diameter or less, and three had disease of 6-10 mm in diameter. The drug was administered weekly in 2 L of Ringer's lactate solution via an indwelling Tenckhoff catheter, and the dose ranged from 30-270 mg per cycle (median 120 mg). The dwell time was 20 minutes. After 12 cycles, response was assessed by open laparoscopy (six patients), laparotomy (eight patients), or peritoneal cytology (three patients). One patient developed distant metastases. Local and systemic toxicity was mild. Delays of therapy were necessary for eight of the 210 cycles because of hematologic toxicity. Of the 15 patients available for pathologic evaluation, four (26.6%) had a complete response and two (13.3%) had a partial response. Results of this pilot study suggest a possible role for intraperitoneal cis-platinum in the management of carefully selected patients with epithelial ovarian cancer.