Status:
TERMINATED
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum
Lead Sponsor:
AGO Study Group
Conditions:
Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
Platinum Sensitve Relapse
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering comple...
Eligibility Criteria
Inclusion
- Relapse longer than 6 months after termination of platinum/taxane based first line chemotherapy
- Previously histologically confirmed cancer of: ovary, fallopian tube, peritoneum
- measurable and evaluable lesions by ultrasound, computer-tomography or MRI
- Performance status ECOG \< 2 or karnofsky index \> 60%
- normal organ function
Exclusion
- more than 1 chemotherapy prior enrollment
- ongoing treatment with epoetin alpha or related drugs
- history of thrombosis or embolism during the past 12 months prior enrollment
- ileus
- left ventricular failure \> NYHA classification \> 2
- Ongoing toxicity of any kind (\> CTC Grad II)
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00189371
Start Date
February 1 2004
End Date
December 1 2005
Last Update
September 19 2005
Active Locations (1)
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1
Department of Gynecology University of Marburg
Marburg, Germany, D-35037