Full Text View
Tabular View
No Study Results Posted
Related Studies
Chemosensitivity Testing to Assign Treatment for Patients With Stage III or Stage IV Ovarian Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsored by: Swiss Group for Clinical Cancer Research
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003214
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized
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 National Cancer Institute (NCI):

Estimated Enrollment: 300
Study Start Date: July 1996
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003214

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

Additional 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.

Study ID Numbers: CDR0000066074, SWS-SAKK-45/94, EU-97036
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003214     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Study placed in the following topic categories:
Immunologic Factors
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Cyclophosphamide
Genital Diseases, Female
Anti-Bacterial Agents
Cisplatin
Ovarian Cancer
Alkylating Agents
Endocrine Gland Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Carboplatin
Antimitotic Agents
Ovarian Epithelial Cancer
Immunosuppressive Agents
Doxorubicin
Carcinoma
Paclitaxel
Tubulin Modulators
Endocrinopathy
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Cyclophosphamide
Ovarian Diseases
Antibiotics, Antineoplastic
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Endocrine Gland Neoplasms
Ovarian Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Paclitaxel
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 02, 2009