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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-12-31

Brief Summary

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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

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Conditions

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Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum Platinum Sensitve Relapse Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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paclitaxel, carboplatin, epoetin alpha

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Christian Jackisch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AGO Study Group

Locations

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Department of Gynecology University of Marburg

Marburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AGO-OVAR 2.7

Identifier Type: -

Identifier Source: org_study_id