Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma

Phase 2 Completed 56 enrolled National Cancer Institute (NCI)

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial is studying the side effects of giving erlotinib together with carboplatin and paclitaxel and to see how well it works in treating patients with stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die.

Timeline

Start: 2003-04
Primary completion: 2010-05
Completion: 2010-05

Outcome

Missed primary endpoint

paper which did not meet the prespecified efficacy endpoint in either stratum. PMID 20837357 ↗

Publications

Results Blank SV, Christos P, Curtin JP, Goldman N, Runowicz CD, Sparano JA, Liebes L, Chen HX, Muggia FM. Erlotinib added to carboplatin and paclitaxel as first-line treatment of ovarian cancer: a phase II study based on surgical reassessment. Gynecol Oncol. 2010 Dec;119(3):451-6. doi: 10.1016/j.ygyno.2010.08.008. Epub 2010 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	150 mg	Oral
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Paclitaxel	Small molecule	175 mg/m2	Intravenous