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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safest and maximum tolerated dose regimen for IV oxaliplatin with intraperitoneal docetaxel and IV oxaliplatin with intraperitoneal docetaxel in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer.
18 months
Yes
Robert P Edwards, MD
Principal Investigator
University of Pittsburgh
United States: Institutional Review Board
OX-06-009
NCT00692900
December 2008
June 2013
Name | Location |
---|---|
Magee-Womens Hospital of UPMC | Pittsburgh, Pennsylvania 15213 |