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Erlotinib Plus Carboplatin and Paclitaxel in Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
NCT00059787Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2003
- Primary completion
- May 2010
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- erlotinib
- Conditions
- ovarian carcinomafallopian tube carcinoma (PFTC)primary peritoneal carcinoma (PPC)
01
Overview
Phase 2, open-label, single-arm trial of erlotinib in ovarian carcinoma, fallopian tube carcinoma (PFTC) and primary peritoneal carcinoma (PPC), sponsored by National Cancer Institute. Primary endpoints: Pathologic Complete Response Rates up to 7 years and Percentage of Participants Experiencing Toxicity up to 7 years. Started Apr 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Paclitaxel, carboplatin, erlotinib
Combination chemotherapy with erlotinib followed by erlotinib maintenance
03
Who it enrols
Patients with stage III (suboptimal or optimal) or stage IV ovarian, fallopian tube, or primary peritoneal carcinoma, no prior chemotherapy within 5 years, and adequate organ function.
04
Endpoints
Primary
Pathologic Complete Response Rates
Percentage of Participants Experiencing Toxicity
Secondary
EGFR Gene Amplification in Tumor Specimens
Progression Free Survival
Tolerability of Maintenance Treatment
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