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

Primary Purpose

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

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
paclitaxel, carboplatin, epoetin alpha
Sponsored by
AGO Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Female

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)

Sites / Locations

  • Department of Gynecology University of Marburg

Outcomes

Primary Outcome Measures

Reduction of anemia

Secondary Outcome Measures

Quality of life
Overall survival
Progression free survival
Toxicity

Full Information

First Posted
September 13, 2005
Last Updated
September 16, 2005
Sponsor
AGO Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00189371
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
AGO Study Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, Platinum Sensitve Relapse, Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel, carboplatin, epoetin alpha
Primary Outcome Measure Information:
Title
Reduction of anemia
Secondary Outcome Measure Information:
Title
Quality of life
Title
Overall survival
Title
Progression free survival
Title
Toxicity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Jackisch, MD, PhD
Organizational Affiliation
AGO Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gynecology University of Marburg
City
Marburg
ZIP/Postal Code
D-35037
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.ago-ovar.de
Description
homepage of the german ovarian cancer study group AGO

Learn more about this 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

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