Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma

Part of paid clinical trials in The Bronx, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00059787
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • paclitaxel — DRUG
    Given IV
  • carboplatin — DRUG
    Given IV
  • erlotinib — DRUG
    Given PO

Study Details

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.

Key Dates

First listed
May 7, 2003
Start date
Apr 30, 2003
Status verified
May 2013
Primary completion
May 31, 2010
Completion
May 31, 2010

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Paclitaxel, carboplatin, erlotinib
    Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib

Primary Outcome Measure

Pathologic Complete Response Rates [ Time Frame: Up to 7 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467-2490-

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