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

NCT00189371 | Terminated Phase 3

• 1 other identifier: AGO-OVAR 2.7
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Reduction of anemia

Secondary Outcomes (4)

• Quality of life

• Overall survival

• Progression free survival

• Toxicity

Interventions

paclitaxel, carboplatin, epoetin alpha DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AGO Study Group: lead

Study Sites (1)

Department of Gynecology University of Marburg

Marburg, D-35037, Germany

Location

Related Links

• homepage of the german ovarian cancer study group AGO

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Anemia

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Christian Jackisch, MD, PhD

  AGO Study Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2004
• Study Completion: December 1, 2005
• Last Updated: September 19, 2005

Record last verified: 2005-09

Locations

DE (1)