Trial Information
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum
Inclusion Criteria:
- 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 Criteria:
- 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Reduction of anemia
Principal Investigator
Christian Jackisch, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
AGO Study Group
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
AGO-OVAR 2.7
NCT ID:
NCT00189371
Start Date:
February 2004
Completion Date:
December 2005
Related Keywords:
- Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
- Platinum Sensitve Relapse
- Anemia
- Anemia
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Neoplasms, Glandular and Epithelial