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NCT00189371 Clinical Trial

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
Secondary ID
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
Est. primary completion date
Accepts healthy volunteers
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

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
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