Rebeccamycin Analogue in Treating Patients With Refractory Stage III or Stage IV Ovarian Epithelial Cancer

NCT ID: NCT00006262

Last Updated: 2012-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2001-09-30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have refractory stage III or stage IV ovarian epithelial cancer.

Detailed Description

OBJECTIVES: I. Determine the response rate to rebeccamycin analogue in patients with refractory stage III or IV ovarian epithelial cancer who have failed platinum in combination with paclitaxel chemotherapy. II. Determine the toxicities of this treatment regimen in these patients.

OUTLINE: Patients receive rebeccamycin analogue IV over 60 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients with complete response after receiving 3 courses receive 3-6 additional courses. Patients with partial response or stable disease after receiving 3 courses receive 3-12 additional courses. Patients with complete response are followed every 2 months for 2 years, and then every 3 months thereafter. All other patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-39 patients will be accrued for this study.

Conditions

Ovarian Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

becatecarin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer Platinum resistant disease as defined by disease progression during or within 6 months of receiving prior paclitaxel combined with cisplatin or carboplatin No elevated CA-125 as only evidence of disease recurrence Measurable disease At least 20 mm in diameter by conventional techniques OR At least 10 mm in diameter by spiral CT scan No known brain metastases

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min Other: No history of allergic reactions to compounds of similar chemical or biologic composition to rebeccamycin analogue No other prior cancer within the past 5 years except nonmelanomatous skin cancer No other medical problems that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent therapeutic agents for cancer

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David A. Fishman, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NU-NCI-00G1

Identifier Type: -

Identifier Source: secondary_id

NCI-1132

Identifier Type: -

Identifier Source: secondary_id

NCI 00G1

Identifier Type: -

Identifier Source: org_study_id