Clinical trial NCT00059787
Conditions: Brenner Tumor Fallopian Tube Cancer Ovarian Clear Cell Cystadenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Cystadenocarcinoma Ovarian Serous Cystadenocarcinoma Ovarian Undifferentiated Adenocarcinoma Stage III Ovarian Epithelial Cancer Stage IV Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2003-04-01; Completion date: 2010-05-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
PRIMARY OBJECTIVES:

I. To establish whether the addition of OSI-774 (Tarceva) to the combination of paclitaxel and carboplatin encourages pathologic complete response (pCR) rates in patients with Stage III optimally cytoreduced (stratum 1) and Stage III suboptimally cytoreduced or Stage IV (stratum 2) ovarian, primary peritoneal or fallopian tube carcinomas when used as front line therapy.

II. To determine the degree and type of toxicity associated with this combined regimen.

SECONDARY OBJECTIVES:

I. To establish baseline epidermal growth factor receptor (EGFR), truncated EGFR (EGFRvIII), phosphorylated EGFR (pEGFR) and related signal transduction pathway protein expression levels (such as the mitogen activated protein kinase p-ERK, AKT phosphorylation and Her2/neu) in tumor samples obtained pretreatment, and to correlate these with achieving pCR.

II. To describe changes in EGFR, EGFRvIII, pEGFR expression levels and other related signal transduction pathway expression occurring during treatment with OSI-774 in combination with chemotherapy.

III. To determine the effect of the addition of OSI-774 (Tarceva) to the combination of paclitaxel and carboplatin on progression-free interval in patients with Stage III optimally cytoreduced (stratum 1) and Stage III suboptimally cytoreduced or Stage IV (stratum 2) ovarian or primary peritoneal carcinomas when used as front line therapy.

IV. To determine the tolerability of twelve months of maintenance treatment with OSI-774 for patients achieving pCR, and to measure the progression-free interval for this population.

V. To document cutaneous effects of OSI 774 prospectively, and to correlate the degree of skin rash with clinical and translational endpoints.

OUTLINE: This is a non-randomized study. Patients are stratified according to disease stage (stage III with optimal residual disease vs stage III with suboptimal residual disease or stage IV).

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.

Arms: arm 1: Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib
Interventions: intervention 1: paclitaxel intervention 2: carboplatin intervention 3: erlotinib
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given PO

Protocol documents: