Safety Study Involving Oxaliplatin With Docetaxel for Recurrent Ovarian,Primary Peritoneal, and Fallopian Tube Cancer

Ovarian Cancer Clinical Trial

Official title: Phase I Dose-Escalation Parallel Studies of Intraperitoneal Oxaliplatin With Intravenous Docetaxel and Intravenous Oxaliplatin With Intraperitoneal Docetaxel in Platinum-Sensitive or Platinum-Resistant Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safest and maximum tolerated dosing regimens for intraperitoneal oxaliplatin with intravenous docetaxel and intravenous oxaliplatin with intraperitoneal docetaxel for recurrent ovarian, primary peritoneal, or fallopian tube cancer.

Clinical Trial Description

This is a non-randomized, open-label Phase I trial in patients with previously treated, recurrent ovarian, primary peritoneal, or fallopian tube cancer. Patients may have either platinum -sensitive (relapse > 12 months from primary therapy) or platinum-resistant (relapse ≤ 12 months from primary therapy) disease.

Up to 20 patients will be enrolled into each of the following arms:

• Arm 1 patients will receive intravenous docetaxel at standard dosing of 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin on day #2 until maximum tolerated dose is achieved.

• Arm 2 patients will receive intravenous oxaliplatin at standard dosing of 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel on day #2 until maximum tolerated dose is achieved.

Treatment will be repeated every 3 weeks until disease progression, intolerable toxicity. ;

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cancer

• NCT number: NCT00692900
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: Phase 1
• Start date: December 2008
• Completion date: October 2013