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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00006262
Recruitment Status : Terminated (Unable to accrue patients to the study.)
First Posted : March 25, 2004
Last Update Posted : June 11, 2012
Information provided by (Responsible Party):

September 11, 2000
March 25, 2004
June 11, 2012
July 2000
September 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006262 on ClinicalTrials.gov Archive Site
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Rebeccamycin Analogue in Treating Patients With Refractory Stage III or Stage IV Ovarian Epithelial Cancer
A Phase 2 Study of BMY-27557-14 (a Rebeccamycin Analog) in Patients With Ovarian Cancer

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.

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.

Phase 2
Primary Purpose: Treatment
Ovarian Cancer
Drug: becatecarin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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September 2001
September 2001   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Female
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NCI 00G1
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Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: David A. Fishman, MD Robert H. Lurie Cancer Center
Northwestern University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP