Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer

NCT ID: NCT00003880

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-28
• Study Completion Date: 2001-08-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with gene therapy using SCH-58500 may kill more tumor cells.

PURPOSE: Randomized phase II/III trial to determine the effectiveness of paclitaxel plus carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III ovarian or stage III primary peritoneal cancer with residual disease following surgery to remove the tumor.

Detailed Description

OBJECTIVES: I. Assess the effect of paclitaxel and carboplatin with or without SCH 58500 on progression free survival, overall survival, safety, response, and CA-125 levels in patients with newly diagnosed stage III ovarian epithelial or primary peritoneal cancer.

OUTLINE: This is a randomized, open label, multicenter study. Patients receive treatment of IV paclitaxel and IV carboplatin. Patients are randomized to one of two treatment groups: Arm I: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Courses are repeated every 21 days. Arm II: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Patients receive intraperitoneal SCH 58500 on days 1-5. Courses are repeated every 21 days. Patients are followed every 6 weeks for 36 months, then every 3 months for 2 years, and then every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

recombinant adenovirus-p53 SCH-58500

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2 mg/dL Glomerular filtration rate no less than 30 Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception No other serious medical condition No other prior malignancies except carcinoma in situ of the cervix, nonmelanomatous skin cancer, Dukes A colorectal cancer from which patient has been disease free for past 5 years, or stage I or II breast cancer from which patient has been disease free for past 10 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent cytokine therapy allowed Chemotherapy: No more than 1 prior chemotherapy course for ovarian or peritoneal cancer At least 10 years since prior adjuvant chemotherapy for breast cancer Endocrine therapy: At least 3 months since prior systemic corticosteroid or other immunosuppressive therapy Concurrent female hormonal replacement allowed Radiotherapy: No prior radiotherapy for ovarian or peritoneal cancer No prior radiotherapy to abdomen Surgery: Prior surgery allowed Other: No other concurrent investigational drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo Ann Horowitz, MD

Role: STUDY_CHAIR

Schering-Plough

Other Identifiers

SPRI-C/I98-102

Identifier Type: -

Identifier Source: secondary_id

SPRI-C98-102

Identifier Type: -

Identifier Source: secondary_id

NCI-V99-1544

Identifier Type: -

Identifier Source: secondary_id

CDR0000067047

Identifier Type: -

Identifier Source: secondary_id

C98102

Identifier Type: -

Identifier Source: org_study_id