Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum

Phase 3

Terminated

• Conditions: Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum; Platinum Sensitve Relapse; Anemia

• Registration Number: NCT00189371
• Lead Sponsor: AGO Study Group

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 complete clinical remission but about 70% will eventually relapse. Relapse more than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment option. Therapy induced anemia is a common problem resulting in decrease of quality of life. The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of therapy induced anemia, rate of transfusions and on quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-16
• Last Update Submitted: 2005-09-16
• Study First Posted: 2005-09-19
• Last Update Posted: 2005-09-19
• Study Completion: 2005-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of anemia

Secondary Outcome Measures

Name	Time	Method
Quality of life
Overall survival
Progression free survival
Toxicity

Trial Locations

Locations (1)

Department of Gynecology University of Marburg; 🇩🇪 Marburg, Germany