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

This study has been terminated.
Sponsor:
Information provided by:
AGO Study Group
ClinicalTrials.gov Identifier:
NCT00189371
First received: September 13, 2005
Last updated: September 16, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
Platinum Sensitve Relapse
Anemia
Drug: paclitaxel, carboplatin, epoetin alpha
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Primary Outcome Measures:
  • Reduction of anemia

Secondary Outcome Measures:
  • Quality of life
  • Overall survival
  • Progression free survival
  • Toxicity

Estimated Enrollment: 300
Study Start Date: February 2004
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189371

Locations
Germany
Department of Gynecology University of Marburg
Marburg, Germany, D-35037
Sponsors and Collaborators
AGO Study Group
Investigators
Principal Investigator: Christian Jackisch, MD, PhD AGO Study Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00189371     History of Changes
Other Study ID Numbers: AGO-OVAR 2.7
Study First Received: September 13, 2005
Last Updated: September 16, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Anemia
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Hematologic Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Neoplasms by Histologic Type
Epoetin Alfa
Carboplatin
Paclitaxel
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 15, 2014