Safety Study Involving Oxaliplatin With Docetaxel for Recurrent Ovarian,Primary Peritoneal, and Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT00692900|
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer||Drug: intravenous docetaxel with intraperitoneal oxaliplatin Drug: intravenous oxaliplatin with intraperitoneal docetaxel||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||October 2013|
intravenous (IV) docetaxel and intraperitoneal (IP) oxaliplatin
Drug: intravenous docetaxel with intraperitoneal oxaliplatin
IV docetaxel 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.
intravenous (IV) oxaliplatin and intraperitoneal(IP) docetaxel
Drug: intravenous oxaliplatin with intraperitoneal docetaxel
IV oxaliplatin 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.
- 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. [ Time Frame: 18 months ]
- To assess quality of life [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692900
|United States, Pennsylvania|
|Magee-Womens Hospital of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Robert P Edwards, MD||University of Pittsburgh|
|Principal Investigator:||Kristin Zorn, MD||University of Pittsburgh|