NCT00069901

Phase II CT-2103/Carboplatin in Ovarian Cancer

CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.

Detailed description

CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.

Conditions

• Ovarian Neoplasm

Interventions

Type	Name	Description
DRUG	CT-2103 (poly(L)glutamate-paclitaxel)
DRUG	carboplatin

Timeline

• Start date: 2003-02-01
• Primary completion: 2005-11-01
• Completion: 2006-09-01
• First posted: 2003-10-06
• Last updated: 2008-09-22

Locations

17 sites across 1 country: United States