A Phase 2 Study of BMY-27557-14 (a Rebeccamycin Analog) in Patients With Ovarian Cancer


Phase 2
21 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

A Phase 2 Study of BMY-27557-14 (a Rebeccamycin Analog) in Patients With Ovarian 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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David A. Fishman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NCI 00G1

NCT ID:

NCT00006262

Start Date:

July 2000

Completion Date:

September 2001

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611