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

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.

Sponsored by:	AGO Ovarian Cancer Study Group
Information provided by:	AGO Ovarian Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00189371

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 III

MedlinePlus related topics:

Anemia Cancer Ovarian Cancer

ChemIDplus related topics:

Carboplatin Epoetin alfa Erythropoietin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by AGO Ovarian Cancer 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 Ovarian Cancer Study Group

Investigators


Principal Investigator:	Christian Jackisch, MD, PhD	AGO Ovarian Cancer Study Group

More Information

homepage of the german ovarian cancer study group AGO This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Epoetin Alfa

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Anemia

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Carboplatin

Ovarian Diseases

Ovarian epithelial cancer

Fallopian Tube Neoplasms

Recurrence

Fallopian Tube Diseases

Genital Diseases, Female

Paclitaxel

Endocrinopathy

Fallopian tube cancer

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Hematinics

Antineoplastic Agents

Hematologic Agents

Mitosis Modulators

Antimitotic Agents

Pharmacologic Actions

Adnexal Diseases

Neoplasms

Neoplasms by Site

Therapeutic Uses

Tubulin Modulators

Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 22, 2008