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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
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Start Date
December 1, 2008
Primary Completion Date
June 1, 2013
Completion Date
October 1, 2013
Last Updated
March 12, 2020
25
ACTUAL participants
intravenous docetaxel with intraperitoneal oxaliplatin
DRUG
intravenous oxaliplatin with intraperitoneal docetaxel
DRUG
Lead Sponsor
University of Pittsburgh
Collaborators
NCT05039801
NCT04550494
Data Source & Attribution
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