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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

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ClinicalTrials.gov Identifier: NCT00189371
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : September 19, 2005
Sponsor:
Information provided by:
AGO Study Group

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.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2004
Study Completion Date : December 2005





Primary Outcome Measures :
  1. Reduction of anemia

Secondary Outcome Measures :
  1. Quality of life
  2. Overall survival
  3. Progression free survival
  4. Toxicity


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00189371     History of Changes
Other Study ID Numbers: AGO-OVAR 2.7
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 19, 2005
Last Verified: September 2005

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