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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00189371
• Other study ID #: AGO-OVAR 2.7
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 16, 2005
• Start date: February 2004
• Est. completion date: December 2005

Study information

• Verified date: September 2005
• Source: AGO Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: December 2005
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Platinum Sensitve Relapse

Intervention

Drug:
• paclitaxel, carboplatin, epoetin alpha

Locations

Country	Name	City	State
Germany	Department of Gynecology University of Marburg	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
AGO Study Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of anemia
Secondary	Quality of life
Secondary	Overall survival
Secondary	Progression free survival
Secondary	Toxicity

External Links

•   homepage of the german ovarian cancer study group AGO