Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer

NCT00006356 | Terminated Phase 3

• 1 other identifier: EORTC-55963
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy with or without surgery in treating patients who have recurrent epithelial ovarian cancer.

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

Interventions

carboplatin DRUG

cisplatin DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed recurrent ovarian epithelial cancer after first line chemotherapy, unless clear evidence of clinically progressive disease * Must have received prior first line chemotherapy consisting of at least 4 courses of either cisplatin or carboplatin * At least 12 months since prior chemotherapy * Measurable disease by clinical exam or diagnostic laparoscopy * At least one lesion greater than 1 cm in diameter * No leptomeningeal or brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.25 times upper limit of normal (ULN) * SGPT less than 2 times ULN Renal: * Creatinine less than 1.6 mg/dL OR * Creatinine clearance greater than 40 mL/min Other: * No peripheral neurotoxicity greater than grade 2 * No psychological, familial, sociological, or geographical condition that would preclude study * No complete bowel obstruction * No other malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No more than 1 prior regimen of chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Spedali Civili

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Giuseppe Favalli, MD

  Ospedale Sta. Maria Delle Croci

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Primary Completion: October 1, 2002
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

IT (1)