CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
paclitaxel +2 moredrug
Likely dose
Erlotinib dose not specified; carboplatin and paclitaxel given IVAI-extracted
Key inclusion· 7
  • Histologically confirmed primary peritoneal carcinoma, fallopian tube, or ovarian carcinoma Stage III with >1 cm residual disease after surgery or Stage IV
  • Appropriate surgical staging with tissue available for histologic evaluation, or unresectable at diagnosis
  • Eligible histologic types: serous, endometrioid, mucinous, undifferentiated, clear cell, mixed epithelial, transitional cell, malignant Brenner's tumor, or adenocarcinoma NOS
  • Must initiate chemotherapy within 12 weeks of surgery
Key exclusion· 6
  • Prior chemotherapy within 5 years
  • Known brain metastases
  • Concurrent investigational agents
  • Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric illness limiting compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00059787
NCT00059787Phase 2Completed

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

National Cancer Institute (NCI)·interventional·Posted May 7, 2003·Updated Dec 1, 2015

In Brief

A Phase 2 clinical trial evaluating paclitaxel, carboplatin, and 1 other intervention for Brenner Tumor and 8 related conditions. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2003
Enrollment StartApr 1, 2003
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 23.2 years ago

Interventions

paclitaxeldrug

Given IV

carboplatindrug

Given IV

erlotinibdrug

Given PO