Chemosensitivity Testing to Assign Treatment for Patients With Stage III or Stage IV Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00003214
First received: November 1, 1999
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

RATIONALE: Chemosensitizers may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.

PURPOSE: Randomized phase III trial to study the effectiveness of chemosensitivity testing to assign treatment for patients with stage III or stage IV ovarian cancer who have undergone surgery.


Condition Intervention Phase
Ovarian Cancer
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: in vitro sensitivity-directed chemotherapy
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III)

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Estimated Enrollment: 300
Study Start Date: July 1996
Study Completion Date: April 2000
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine whether the use of a chemosensitivity assay to assign treatment improves the time to progression and response rates of patients with stage III/IV ovarian cancer.

OUTLINE: This is a randomized study. Patients are stratified according to size of tumor after debulking surgery, stage, and Swiss Group for Clinical Cancer Research center where treatment is received. Within 14 days after patients undergo debulking surgery, they are randomized to one of two treatment arms. Arm I: Patients randomized to this arm receive one of six treatment regimens: Regimen A - cisplatin/cyclophosphamide Regimen B - cisplatin/cyclophosphamide/doxorubicin Regimen C - carboplatin Regimen D - carboplatin/cyclophosphamide Regimen E - cisplatin/paclitaxel Regimen F - carboplatin/paclitaxel Arm II: Patients who are randomized to this arm are assigned a treatment regimen based on a chemosensitivity assay of tumor specimens collected after debulking surgery. If no valid assay result is obtained, patients receive carboplatin/cyclophosphamide. Treatment is repeated every 3-4 weeks for a total of 6 courses. Up to 4 more courses may be administered if a partial response is demonstrated. Patients are followed every 3 months for the first 2 years and every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 300 patients will be accrued for this study over 6 years.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically/pathologically confirmed stage III and IV ovarian cancer Complete surgical staging and debulking including total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and biopsies of suspicious lesions (if feasible) required No low malignant potential histology without any invasive lesions in the peritoneum

PATIENT CHARACTERISTICS: Age: 80 and under Performance status: 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No disorder that would prevent the application of any protocol treatment

PRIOR CONCURRENT THERAPY: See Disease Characteristics

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003214

Locations
Switzerland
Kantonspital Aarau
Aarau, Switzerland, 5001
Office of Walter Weber-Stadelman
Basel, Switzerland, CH 4051
Frauenspital, Basel
Basel, Switzerland, 4031
University Hospital
Basel, Switzerland, CH-4031
Inselspital, Bern
Bern, Switzerland, CH-3010
Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland, CH-1211
Istituto Oncologico della Svizzera Italiana
Lugano, Switzerland, CH-6900
Burgerspital, Solothurn
Solothurn, Switzerland, 4500
Klinik Hirslanden
Zurich, Switzerland, CH-8008
City Hospital Triemli
Zurich, Switzerland, 8063
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: O.R. Kochli, MD Frauenspital, Basel
  More Information

Publications:
Koechli OR, Delaloye JF, Maibach R, et al.: Ovarian carcinoma FIGO II and IV - results of a randomized multicenter feasibility study with the ATP cell viability chemosensitivity assay. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-1326, 1997.

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00003214     History of Changes
Other Study ID Numbers: SAKK 45/94, SWS-SAKK-45/94, EU-97036
Study First Received: November 1, 1999
Last Updated: May 14, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian 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
Cisplatin
Cyclophosphamide
Doxorubicin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators

ClinicalTrials.gov processed this record on July 20, 2014