Clinical Trial: Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Erlotinib Plus Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

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 Summary:

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.

  • Pathologic Complete Response Rates [ Time Frame: Up to 7 years ]
    Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.
  • The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen [ Time Frame: For the duration of the study up to 7 years ]
    Adverse event assessment


    • Original Primary Outcome:

    Current Secondary Outcome:

    • To Measure EGFR Gene Amplification in Tumor Specimens [ Time Frame: The duration of the study for up to 7 years ]
    • To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin [ Time Frame: The duration of the study ]
    • To Determine the Tolerability of Twelve Months of Maintenance Treatment [ Time Frame: Twelve months of maintenance ]


    Original Secondary Outcome:

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: May 6, 2003
    Date Started: April 2003
    Date Completion:
    Last Updated: October 29, 2015
    Last Verified: May 2013