The Primary Endpoint Was Time-to-progression Research Articles

Phase I/II study of first-line combination therapy with sorafenib plus resminostat, an oral HDAC inhibitor, versus sorafenib monotherapy for advanced hepatocellular carcinoma in east Asian patients

Resminostat is an oral inhibitor of class I, IIB, and IV histone deacetylases. This phase I/II study compared the safety and efficacy of resminostat plus sorafenib versus sorafenib monotherapy as first-line therapy for advanced hepatocellular carcinoma (HCC). In phase I, resminostat (400mg or 600mg/day on days 1 to 5 every 14days) was administered with sorafenib (800mg/day for 14days) to determine the recommended dose for phase II. In phase II, patients were randomized (1:1) to sorafenib monotherapy or resminostat plus sorafenib. The primary endpoint was time-to-progression (TTP). Nine patients (3: 400mg, 6: 600mg) were enrolled in phase I, and the recommended dose of resminostat was determined to be 400mg/day. Then 170 patients were enrolled in phase II. Median TTP/overall survival (OS) were 2.8/14.1months with monotherapy versus 2.8/11.8months with combination therapy (Hazard Ratio [HR]: 0.984, p = 0.925/HR: 1.046, p = 0.824). The overall incidence of adverse events was similar in both groups (98.8% versus 100.0%). However, thrombocytopenia ≥ Grade 3 was significantly more frequent in the combination therapy group (34.5% versus 2.4%, p < 0.001). Subgroup analysis revealed that median TTP/OS was 1.5/6.9months for monotherapy versus 2.8/13.1months for combination therapy (HR: 0.795, p = 0.392/HR: 0.567, p = 0.065) among patients with a normal-to-high baseline platelet count (≥ 150 × 103/mm3). In patients with advanced HCC, first-line therapy with resminostat at the recommended dose plus sorafenib showed no significant efficacy advantage over sorafenib monotherapy.

Neoadjuvant denosumab for the treatment of resectable giant cell tumor of bone: First results of Russian multicenter study.

11521Background: Giant cell tumor of bone (GCT) is a relatively rare, benign but locally aggressive osteolytic skeletal neoplasm of young adults. This study is non-interventional observational GCT treatment study in the Russian Federation (RF). Designed to detect epidemiology data as well as the clinical efficiency of surgical and/or denosumab (Db) treatment of GCT in the RF. Methods: Between August 2016 and October 2017, 112 adult patients (pts) with GCT were enrolled. Ten Russian Cancer Center are included in this study. The primary endpoint was Time-To-Progression (TTP). Adult and skeletally mature adolescent pts with resectable and unresectable GCT (N = 54) received subcutaneous Db 120 mg every 4 weeks with a loading dose of 120 mg SC on study days 8 and 15. Options for surgical treatment (N = 25) include intralesional curettage (InC) (alone or followed by filling of the defect with bone cement), marginal excision (MEx), a wide local excision, or en bloc resection with or without reconstructive surger...

A multi-center phase II study and biomarker analysis of combined cetuximab and modified FOLFIRI as second-line treatment in patients with metastatic gastric cancer

sBackgroundTo evaluate the efficacy of cetuximab combined with modified FOLFIRI (mFOLFIRI) as a second-line treatment in metastatic gastric cancer patients and to identify potential biomarkers of clinical outcomes.MethodsAll 61 patients received an initial intravenous (IV) dose of cetuximab (400 mg/m2) and weekly doses (250 mg/m2) thereafter, starting on day 1. On day 2 of each 14-day period, patients received IV irinotecan (180 mg/m2), leucovorin (200 mg/m2), and an IV bolus dose of 5-FU (400 mg/m2) followed by a continuous infusion of 5-FU (2400 mg/m2) for 46 h. The primary endpoint was time-to-progression (TTP).ResultsThe response rate (RR) was 33.3% among 54 evaluable patients. In the intention-to-treat analysis, median TTP was 4.6 months (95% confidential interval [CI]: 3.6-5.6 months) and median overall survival (OS) was 8.6 months (95% CI: 7.3-9.9 months). In univariate analyses, plasma vascular endothelial growth factor (VEGF) levels were correlated with clinical outcome. In patients with low (≤12.6 pg/ml) and high (>12.6 pg/ml) baseline plasma VEGF levels, RR values were 55.0% and 5.3%, respectively (P = 0.001); median TTP values were 6.9 months and 2.8 months, respectively (P = 0.0005); and median OS values were 12 months and 5 months, respectively (P <0.0001). None of these patients exhibited KRAS, BRAF, or PIK3CA mutations.ConclusionsCombination therapy comprising cetuximab and mFOLFIRI was well tolerated and active as a second-line treatment for patients with metastatic gastric cancer. Patients with low baseline plasma VEGF levels were associated with better clinical outcomes.Trial registrationClinicalTrials.gov. NCT00699881. Registered 17 June 2008 (retrospectively registered)

Active surveillance for metastatic or recurrent renal cell carcinoma.

Metastatic renal cell carcinoma (mRCC) sometimes presents with an indolent course without any significant symptoms. Here, the potential impact of active surveillance (AS) on clinical outcomes in asymptomatic or minimally symptomatic mRCC patients was retrospectively evaluated. mRCC patients who were followed up with deferred treatment for the purpose of AS between 2000 and 2012 were enrolled. Patient and disease characteristics, outcomes of AS and subsequent therapies, and predictive factors for rapid disease progression were analyzed. The primary endpoint was time-to-progression (TTP). First-line systemic therapy was deliberately deferred in 58 patients. During AS, the best overall responses were stable disease for 48 patients (83 %) and progressive disease (PD) for 10 patients (17 %), and 47 patients ultimately experienced disease progression at the time of data cutoff. With a median follow-up of 31.4 months, the median TTP was 12.4 months (95 % confidence interval 8.4-16.5) and median overall survival was not reached. After univariate and multivariate analyses for TTP, Karnofsky performance status <100 %, liver metastasis, and a time from diagnosis to AS of less than 1 year were found to be predictive factors for a shorter TTP. After PD, 30 patients received systemic treatment (14 sunitinib, 11 pazopanib, 4 immunotherapy, and 1 temsirolimus). The objective response rates were 71 % for sunitinib and 46 % for pazopanib, which were deemed comparable with historical controls. Asymptomatic or minimally symptomatic mRCC patients can be observed for a prolonged period of time without active treatment.

The Utility Of Minimal Residual Disease (MRD) Assessment At First Relapse: Results From The BSBMT/Ukmf Myeloma X (Intensive) Trial

IntroductionMinimal residual disease (MRD) assessment by multicolour flow cytometry (MFC) following upfront therapy is a powerful prognostic tool in multiple myeloma (MM) and there is growing evidence supporting its role as an outcome measure in clinical trials. There is however no published data assessing its utility in the relapse setting. Our aim was to test the utility of MFC at first relapse following a second autologous transplant (ASCT2) or weekly cyclophosphamide (C-weekly) consolidation following re induction chemotherapy in patients entered into the BSBMT/UKMF Myeloma X trial. Patients and MethodsEligible MM patients relapsing after a prior ASCT were enrolled and received a bortezomib-containing re-induction regimen (PAD, Bortezomib, Doxorubicin and Dexamethasone) before being randomized to either ASCT2 or C-weekly. The primary endpoint was time-to-progression (TTP) with secondary endpoints of overall survival and overall response rate (to PAD and randomized intervention). Bone marrow aspirate samples were analyzed by MFC at trial entry to establish neoplastic phenotype and then at specified time-points following treatment. After red cell lysis and washing, samples were labelled with CD27-FITC, CD56-PE, CD19-PerpCPCy5.5, CD38-PE-Cy7, CD138-APC and CD45-APC-Cy7. A minimum of 500,000 events were acquired on a FacsCanto II cytometer and data was analyzed using a standardized gating strategy. Sensitivity of the assay is 0.01% of leucocytes. Response assessment (after re-induction, 100 days post-ASCT2 or 30 days post C-weekly) and disease progression were determined using IMWG criteria. Unfavourable genetic abnormalities were defined as FGFR3/IGH, IGH/MAF and TP53 deletion by interphase FISH. Results297 patients with a median age of 61 (range 38 -75) were entered into the study and 174 randomized from April 2008 to November 2012: ASCT2 n=89, C-weekly n=85. Of the whole trial cohort, MFC analysis was available in 224 at presentation, 162 at completion of re-induction therapy, 46/89 at D100 post ASCT2 and 50/85 at D30 post C-weekly.In an intention to treat analysis of all available randomized patients, achieving MRD negativity was highly predictive for improved TTP: All patients (MRD+ 12mns 95%CI 10-13 vs. MRD- 24mns 95CI NR; logrank P=0.0003), ASCT arm (MRD+ 15mns 95%CI 11-19 vs. MRD- 24mns 95%CI 16-42; logrank P=0.0227) & C-weekly arm (MRD+ 11mns 95%CI 8-12 vs. MRD- 15mns 95%CI 9-NR) logrank P=0.0107).MRD status was also assessed in conjunction with IMWG conventional categorical response assessment. CR was demonstrable in 39% of patients post ASCT2 and 22% of patients following C-weekly. The presence of MRD predicted outcome in those patients achieving a CR and the most favourable outcome was seen in CR/MRD- patients (<CR/MRD+ 11 mns (95%CI 9-12 mns), <CR/MRD- 16 mns (95%CI 4-29 mns), CR/MRD+ 10 mns (95%CI 7-24 mns) and CR/MRD- 25 mns (95%CI 15-41 mns); logrank p<0.0001). [Display omitted] MRD status was also assessed according to cytogenetic risk group as defined by interphase FISH. Adverse cytogenetics were present in 19% of patients. Achieving MRD negativity was associated with an improved outcome in patients with both favourable and adverse cytogenetic profiles: Adverse; MRD+ 10 mns (95%CI 8-11 mns), MRD- 23 mns (95%CI 16-25 mns), Favourable; MRD+ 11 mns (95%CI 9-13 mns), MRD- 16mns (95%CI 10-NR mns); logrank p= 0.0058. ConclusionThese data clearly demonstrate that MRD assessment by MFC is a sensitive predictor of outcome in the first relapse setting, irrespective of the consolidation therapy given. MRD assessment predicts outcome in patients achieving CR and is applicable to patients with both favourable and adverse cytogenetics. This data is comparable to that published by us and others in the context of primary therapy and suggests that MRD assessment is an appropriate outcome measure in relapsed MM. Disclosures:Williams:Janssen: Honoraria, Speakers Bureau. Snowden:Janssen: Honoraria, Research Funding, Speakers Bureau.

A multicenter phase II study of sorafenib, capecitabine, and oxaliplatin (SECOX) in patients with advanced hepatocellular carcinoma: Final results of Hong Kong-Singapore Hepatocellular Carcinoma Research Collaborative Group study.

4117 Background: This is a single arm, multi-center, phase II study to assess the efficacy and tolerability of sorafenib, oxaliplatin and capecitabine combination for the treatment of advanced hepatocellular carcinoma (HCC) patients. Methods: Eligible patients received SECOX regime—sorafenib 400 mg bid (Day one-fourteen), oxaliplatin 85 mg/m2 (Day one) and capecitabine 1700 mg/m2(Day one-seven) every two weeks. Response assessment was based on RECIST 1.0 criteria. The primary endpoint was time-to-progression (TTP) and the secondary endpoints were tumor response rate (RR), progression-free survival (PFS), overall survival (OS) and tolerability. Results: A total of 51 patients were enrolled in the trial.The median age was 58 years (range, 28-81) and 84% of patients were chronic hepatitis B carriers. Ninety percent of recruited patients belonged to BCLC stage C disease and 41 (80%) patients had extra-hepatic metastasis. The best RR was 16% and they were all partial response. Another 62% of patients achieved stable disease for at least eight weeks. The median TTP was 5.29 months (95% CI 3.81-5.88 months), PFS 5.26 months (95% CI 3.75-5.88 months) and OS was 11.73 months (95% CI 8.87- 15.38 months). Diarrhea (75%), Hand-foot-skin reaction (73%) and transient liver function derangement were the most commonly encountered adverse events, with the majority of patients having grade one or two. No treatment-related death was reported. Conclusions: The SECOX regime indicates preliminary promising activity and safety in Asian population with advanced HCC. Our data support a randomized trial comparing SECOX versus sorafenib alone for treatment of advanced HCC. Clinical trial information: NCT00752063.

696P - A Multi-Center Phase II Study and Predictive Biomarker Analysis of Combined Cetuximab and Modified Folfiri as Second-Line Treatment in Patients with Metastatic Gastric Cancer

ABSTRACT Background This study was conducted to explore potential biomarkers for predicting clinical outcome of cetuximab in combination with modified FOLFIRI (mFOLFIRI) and to analyze safety of this regimen as a second-line treatment in metastatic gastric cancer patients. Methods A total of 61 patients received an initial intravenous (IV) dose of cetuximab (400 mg/m2) and weekly doses (250 mg/m2) thereafter. On day 2 of each 14-day period, patients received IV irinotecan (180 mg/m2), leucovorin (200 mg/m2), and an IV bolus dose of 5-FU (400 mg/m2) followed by a continuous infusion of 5-FU (2400 mg/m2) for 46 hours. The primary endpoint was time-to-progression (TTP). Findings The response rate (RR) was 33.3% among 54 evaluable patients. In the intention-to-treat (ITT) analysis, median TTP was 4.6 months (95% confidential interval [CI]: 3.6-5.6 months) and median overall survival (OS) was 8.6 months (95% CI: 7.3-9.9 months). It was demonstrated that plasma vascular endothelial growth factor (VEGF) levels could be a predictive factor for the treatment prognosis. In patients with low (≤12.6 pg/ml) and high (>12.6 pg/ml) baseline plasma VEGF levels, RR values were 55.0% and 5.3%, respectively (P = 0.001); median TTP values were 6.9 months and 2.8 months, respectively (P = 0.0005); and median OS values were 12 months and 5 months, respectively (P Interpretation Low baseline plasma VEGF levels were identified as a potential predictive biomarker of prognosis. Combination therapy comprising cetuximab and mFOLFIRI was well tolerated, which would be potentially used as a second-line treatment for patients with advanced gastric cancer. Funding This study was supported by Fudan University Shanghai Cancer Center; Merck KGaA Darmstadt, Germany, and National “Eleventh Five-year plan” new drug discovery major projects of P. R. China. Disclosure All authors have declared no conflicts of interest.

Safety and activity of masitinib in combination with gemcitabine in patients with advanced pancreatic cancer

To evaluate the efficacy and safety of masitinib combined with gemcitabine in patients with advanced pancreatic cancer. Twenty-two non-randomised patients with unresectable, locally advanced (n = 9) or metastatic pancreatic cancer (n = 13) received oral masitinib (9 mg/kg/day) combined with standard gemcitabine. All patients were naive to systemic chemotherapy or radiotherapy. The primary endpoint was time-to-progression (TTP) with efficacy and safety analyses performed on the intent-to-treat population. Secondary endpoints included overall survival (OS), as well as, subgroup analyses according to baseline disease, and performance status. Overall median TTP was 6.4 months (95% CI [2.7-11.7]); 8.3 and 2.7 months, respectively, for locally advanced and metastatic patients; 6.4 and 0.8 months, respectively, for patients with KPS [80-100] or KPS [70]. Median OS was 7.1 months (95% CI [4.8-17.0]); 8.4 and 6.8 months for locally advanced or metastatic patients, respectively; 8.0 and 4.4 months in patients with KPS [80-100] or KPS [70], respectively. The 18-month observed survival rate was similar for locally advanced (22%) and metastatic patients (23%) and reached 28% for KPS [80-100] patients. The most common suspected adverse events were nausea, vomiting, rash, diarrhoea, peripheral oedema, anaemia, lymphopenia, thrombocytopenia, pyrexia, neutropenia, asthenia, leucopenia, and abdominal pain, and most were of grades 1-2 severity. The efficacy and safety of masitinib combined with gemcitabine are encouraging, with extended survival and median TTP that support initiation of a phase 3 trial.

OPTIMUM Dose of Thalidomide for Relapsed Multiple Myeloma.

Abstract 959 Introduction:The OPTIMUM trial was designed to compare the efficacy of single-agent Thalidomide (THAL) with high-dose Dexamethasone (DEX) in patients with relapsed refractory (RR) multiple Myeloma (MM) and to determine the optimal dose of THAL in these patients. Methods:Patients with RRMM who had progressed after 1-3 lines of prior therapy were eligible for this multinational, randomized, open label phase III study. Patients were randomized to either daily THAL 100mg (THAL 100), 200mg (THAL 200) or 400mg (THAL 400), or DEX (40mg daily on days 1-4, 9-12 and 17-20 of each 28 day cycle for four cycles. From cycle 5 onwards, the dosing schedule was reduced to 40mg daily on days 1-4 of each cycle). All patients received study medication until disease progression or for a maximum of 12 cycles. Anticoagulant prophylaxis was not given routinely. Stratification factors included number of prior lines of therapy (1 versus > 1), prior autologous stem cell transplantation (ASCT) and International Staging System (ISS) score (Stage I+II versus III). The primary endpoint was time-to-progression (TTP) validated by an Independent Review Committee (IRC). Secondary endpoints included response rate, clinical benefit, survival, quality of life and safety. Planned accrual was 496 patients in order to detect a significant difference of 3 months in median TTP between the arms with 82% power at a two-sided significance level of 0.05. Results:Between Apr 2006 and Feb 2008, 499 patients were randomized by 68 sites in 15 countries from Europe, Asia and South Africa. Median age was 64 years (range 33-86); 73% of patients had ISS Stage I+II; 56.7% had received one prior therapy, 29.7% had received 2 and 12.8% had received 3 prior lines; 14.4% of patients had received prior bortezomib. Patients who had received prior thalidomide or lenalidomide were not included in this trial. Based on IRC-confirmed disease progressions during the treatment phase of the study, median TTP in the THAL 400 and in the DEX groups were 9.9 versus 6.0 months (hazard ratio, 0.64; p=0.017). Median TTP of the THAL 100 and THAL 200 arms were 6.7 and 7.3 months, respectively. IRC-validated complete and partial response rates according to EBMT criteria were 20.7% with THAL 100, 18.0% with THAL 200, 21.5% with THAL 400, and 24.6% with DEX. However, duration of response (DOR) showed a clear benefit for patients responding to THAL in comparison to DEX (median DOR in months: THAL 100: 12.7, p=0.046; THAL 200: 13.1, p=0.005; THAL 400: 11.6, p=0.016; DEX: 6.5). There was no difference in one year overall survival between the groups (80%, 83%, 82% and 80% for THAL 100, THAL 200, THAL 400 and DEX, respectively). During the study treatment period, the median of average daily drug dose in the THAL 100, THAL 200, THAL 400 and DEX groups were 99.5 mg, 198.2 mg, 255.5 mg and 40 mg, and the median treatment duration was 185, 179, 195, and 144 days, respectively. 60.2% of patients treated with THAL 400 had at least one treatment emergent AE (TEAE) ≥ Grade 3 compared to 39.5% with DEX. Thalidomide caused more frequent nervous system events (16.4 versus 2.4%), ≥ Grade 3 blood and lymphatic system disorders (14.8 versus 4.8%) and general disorders (12.5 versus 8.1%). Infections ≥ Grade 3 were more frequent with DEX (10.5% versus 8.6%). However, since TEAE of Grade 4 or higher were similar between both groups (12.5 versus 11.3%), the higher number of grade 3/4 events in the THAL 400 arm is due to an increase in grade 3 but not grade 4 TEAE with THAL 400 versus DEX. Venous thromboembolic events were uncommon in both groups (1.6% with DEX versus none with THAL 400). Patients treated with lower doses of THAL showed a more favorable safety profile. TEAEs of grade 3 or higher occurred in only 38.2 and 32.0% of the patients treated in the THAL 200 and 100 arms, respectively. Conclusion:This study is the first trial to evaluate the single agent activity of THAL in RRMM patients in a randomized controlled setting. Patients treated with THAL showed longer disease control in terms of TTP and DOR compared to high-dose DEX. The results confirm that THAL is a good treatment option for these patients with a dose dependent safety profile. Disclosures:Kropff:Celgene, ORTHO BIOTECH: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Off Label Use: In Europe, thalidomide is not approved for the treatment of relapsed multiple myeloma. . Robak:Celgene: Consultancy, Research Funding. Hajek:Janssen-Cilag: Honoraria. Liebisch:Celgene, ORTHO BIOTECH: Honoraria. Blade:Janssen-Cilag: Honoraria; Celgene: Honoraria. Caravita:Celgene: Honoraria. Pattou:Celgene: Employment. Lucy:Celgene: Employment, Equity Ownership. Kueenburg:Celgene: Employment. Glasmacher:Celgene: Employment, Equity Ownership. Zerbib:Celgene: Employment. Facon:Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen Cilag: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Phase III open-label comparison of gemcitabine/oxaliplatin versus paclitaxel/carboplatin as first line therapy for advanced non-small cell lung cancer (NSCLC)

8024 Background: Platinum-based doublets are the standard of care for advanced and metastatic NSCLC. Gemcitabine/cisplatin is one of the most active regimens; however many patients cannot tolerate the non-hematological side effects of this combination. This study was designed to compare the efficacy and tolerability of Gemcitabine + Oxaliplatin (GEMOX) to that of Paclitaxel/Carboplatin (PCb) in chemotherapy-naïve Stage IIIB/IV NSCLC patients. Methods: Newly diagnosed patients greater than 18 years of age with histologically proven NSCLC and ECOG PS ≤ 1 were randomly assigned 1:1 and stratified by stage (IIIB vs IV) in a 1:4 proportion to receive either PCb (P 225 mg/m2 day 1 followed by Cb AUC = 6) or GEMOX (GEM 1000mg/m2 days1 and 8 and OX 130 mg/m2 on day 1 after GEM) for a maximum of 6 cycles. The primary endpoint was time-to-progression (TTP), with tumor response rate, overall survival (OS), and quality of life (QoL) as secondary endpoints. Results: A total of 383 patients were randomized; 371 patients received treatment and have full safety data available (184 patients received GEMOX; 187 patients received PCb). Of the 371 patients with safety data, 204 (55.0%) were male, 193 (52.0%) < 65 years old, 340 (91.6 %) were Caucasian and 6 (1.6%) Hispanic, 193 (52.0 %) had an ECOG score = 0, 302 (81.4%) had Stage IV disease at diagnosis and 33 (8.9%) had brain metastases. Mean ± SD number of cycles completed was 4.1 ± 1.8 (range 1–6). There were 26 deaths (7.0%) within 30 days of completing treatment. At the end of the follow-up period (684 days from start of study treatment) 38 pts (10.2%) were still alive. Neutropenia (32.9%) and thrombocytopenia (17.3%) were the most common Grade 4 toxicities. Conclusions: Additional safety and full efficacy data will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration sanofi-aventis sanofi-aventis

A phase II trial of high-dose calcitriol and docetaxel in patients with untreated, incurable pancreatic adenocarcinoma

15099 Background: Taxanes have activity in patients with advanced pancreatic adenocarcinoma. In preclinical studies, calcitriol, the active form of vitamin D, potentiates docetaxel-induced cell death in pancreatic and prostatic cancer cell lines. Clinically, single institution and randomized prostate cancer trials using weekly high-dose calcitriol with docetaxel have demonstrated high PSA response rates (J Clin Oncol 2003, 2007). Herein we report results from a phase II study of the identical regimen in patients with incurable pancreatic adenocarcinoma. Methods: Patients with a histologic diagnosis of locally advanced or metastatic pancreatic adenocarcinoma, Zubrod PS 0–2, and adequate organ function were eligible. Previous non-docetaxel adjuvant chemotherapy and radiation were permissible. Patients received calcitriol 0.5 mcg/kg orally day 1, followed by docetaxel 36 mg/m2 on day 2. Therapy was given weekly for 3 weeks, followed by a 1 week break, and patients were treated until progression. The primary endpoint was time-to-progression (TTP). Results: 24 patients with metastatic and 1 with locally advanced (25 total) were enrolled, treated and are evaluable for efficacy and toxicity. Median age and PS were 60 (range 30 to 79) and 1, respectively. 68% were males, and all were white. Three patients are alive and 22 have died. The median number of cycles was 1 (range 0 to 12). 3 patients (12%, 95% CI 3 to 31) achieved a partial response, and 7 (28%) stable disease for at least 7 weeks. Median TTP and median overall survival were 2.2 and 5 months respectively. Potentially treatment-related common grade 3/4 toxicities included: thrombosis -12%, abnormal LFTs-16%, nausea-8%, fatigue-16%, infection-12%, neutropenia/leucopenia-16%, effusion-8%, abnormal electrolytes-24%, and infusion reaction-4%. Conclusions: The combination of docetaxel and high-dose calcitriol has activity in pts with advanced pancreatic cancer, but the regimen offers no apparent advantage over historical results achieved with standard gemcitabine. No significant financial relationships to disclose.