A PHASE II STUDY OF OSI 774 IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH OVARIAN, CANCER OF THE FALLOPIAN TUBE OR PRIMARY PERITONEAL CARCINOMA
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
II. To determine the degree and type of toxicity associated with this combined regimen.
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
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response
Up to 7 years
Montefiore Medical Center
United States: Food and Drug Administration
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