G0076HH A Limited Access Phase I/II Trial of Paclitaxel, Cisplatin and ABT-888 (Velaparib) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
- To determine the maximum tolerated dose (MTD) and dose-limiting toxicities of ABT-888 when combined with cisplatin and paclitaxel in women with advanced, persistent, or recurrent cervical cancer. - To examine the safety of administering ABT-888 when combined with cisplatin and paclitaxel. -Once the recommended phase II dose is established, this study will aim to estimate the efficacy of cisplatin, paclitaxel, and ABT-888 with respect to objective tumor response in patients with advanced, persistent or recurrent carcinoma of the cervix.
- Primary stage IVB, recurrent or persistent cervix ca - Must have prior chemo/radiation for Phase I portion - 6 weeks out from chemo/radiation - Adjuvant chemo following chemo/rt allowed up to 4 cycles - must have measurable disease for Phase II
Day 1 â?? Taxol over 3 hrs Day 2 â?? Cisplatin over 1 hr Days 1-7 â?? Oral ABT-888 (parp inhibitor) Cycle equal to 21 days
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