Abstract
7136 Background: Ortataxel is a novel second-generation taxane, with potent growth inhibitory activity against human cell lines that express P-glycoprotein 170. Compared to paclitaxel and docetaxel, it is 20–30 times more potent as a growth inhibitory agent against human breast and colon tumor cell lines expressing P-gp 170. Ortataxel is also active in NSCL tumor xenografts. Based on these preclinical and additional phase I data, this phase II study was initiated to assess the safety and efficacy (response rate) of Ortataxel in patients (pts) with taxane-resistant NSCLC. Methods: Ortataxel was administered IV over 60 min every 3 wks at a dose of 75 mg/m2. Pts with taxane resistant NSCLC, with at least one measurable lesion, ECOG score 0, 1, or 2, adequate hematology and biochemistry, and no more than 2 prior anticancer chemotherapy regimens were eligible. Taxane resistance was defined as PD during treatment (Rx) or within 6 months of Rx with a prior taxane. The protocol was amended to include pts with brain metastases (BM). Results: 98 pts were enrolled. Clean data is available for the first 65 pts: 25 F, 40M; median age 60 (38 - 77); ECOG 0/1/2 - 19/37/9 respectively; prior chemo regimens: 0 (0 pt.), 1 (29 pts.), 2 (34 pts.), 3 (2 pts. received Iressa as 3rd regimen). Median number of cycles administered: 2 (1–11). 89% (58) pts received >90% planned dose intensity. Common drug related non-hematological toxicities included: fatigue 25(38%), nausea 19(29%), myalgia 18(27%), sensory neuropathy 17(26%), vomiting 15(23%), constipation 14(21%), diarrhea 11(17%), arthralgia 10(15%), alopecia 9(13%), stomatitis/pharyngitis 9(13%). Hematologic toxicities seen: G 3–4 neutropenia 49%, G3–4 anemia 7%. 4(6%) pts (without BM) had a PR, 25(38%) pts had SD, 31(48%) pts had PD. 5 pts were not evaluable (missing post baseline evaluations due to consent withdrawal in 2 pts and AE's in 3 pts). Conclusion: Four investigator-confirmed partial responses to Ortataxel were documented in this trial so far. An independent review is underway. The study continues to enroll only pts with BM in order to assess the drug in this subset of patients. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bayer Healthcare; Pharma-Clinical Ltd.
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