NCT00063401

Phase II Study in Patients With Epidermal Growth Factor Receptor (EGFR) + Advanced Stage Ovarian, Primary Peritoneal and Fallopian Tube Cancer

A Phase II Study of Cetuximab (C225)/Paclitaxel/Carboplatin for the Initial Treatment of Advanced Stage Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.

Detailed description

The population being studied in this trial is subjects with advanced stage ovarian, primary peritoneal and fallopian tube cancer will be enrolled. By receiving combination therapy with cetuximab (C225)/paclitaxel/carboplatin, these subjects will experience longer progression-free survival than previously reported for subjects receiving only paclitaxel and carboplatin.

Conditions

• Ovarian Cancer
• Peritoneal Neoplasms
• Fallopian Tube Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Cetuximab:	400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles
DRUG	Paclitaxel	175 mg/m2 Day 1, six 21-day cycles
DRUG	Carboplatin	AUC = 6 Day1, six 21-day cycles

Timeline

• Start date: 2003-09-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2003-06-27
• Last updated: 2010-04-08

Locations

2 sites across 1 country: United States