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

Ovarian Cancer Clinical Trial

Official title:

Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003214
• Other study ID #: SAKK 45/94
• Secondary ID: SWS-SAKK-45/94EU
• Status: Completed
• Phase: Phase 3
• Start date: July 1996
• Est. completion date: April 2000

Study information

• Verified date: May 2019
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2000
• Est. primary completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• carboplatin

• cisplatin

• cyclophosphamide

• doxorubicin hydrochloride

• in vitro sensitivity-directed chemotherapy

• paclitaxel

Locations

Country	Name	City	State
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Frauenspital, Basel	Basel
Switzerland	Office of Walter Weber-Stadelman	Basel
Switzerland	University Hospital	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Hopital Cantonal Universitaire de Geneva	Geneva
Switzerland	Istituto Oncologico della Svizzera Italiana	Lugano
Switzerland	Burgerspital, Solothurn	Solothurn
Switzerland	City Hospital Triemli	Zurich
Switzerland	Klinik Hirslanden	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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.

Mariotta M, Perewusnyk G, Koechli OR, Little JB, von Knebel Doeberitz M, Mirimanoff RO, Rutz HP. Dexamethasone-induced enhancement of resistance to ionizing radiation and chemotherapeutic agents in human tumor cells. Strahlenther Onkol. 1999 Aug;175(8):39 — View Citation