Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Closed 15 and over MDA-MBDT-8085

Objectives

I.  Compare the therapeutic efficacy (in terms of response rate and survival) 
of two different schedules of dihydroxyanthracenedione and vinblastine in 
patients with metastatic breast cancer who have failed protocols of higher 
priority.
II.  Compare the qualitative and quantitative toxicities of these agents given 
on the two schedules.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 15 years of age or older 
with measurable, histologically proven metastatic breast cancer who are not 
candidates for known regimens or protocol treatments of greater efficacy or 
priority.  At least 15 patients entered on each arm of this study will have 
undergone no more than two prior therapeutic regimens; patients with more than 
4 prior regimens are ineligible.  Patients must have been off all 
chemotherapy, hormonal therapy, immunotherapy, and radiotherapy for 4 weeks 
prior to study entry, and they must be recovered from toxicities of such 
therapy; this restriction does not apply to localized radiotherapy to an area 
that does not compromise bone marrow.  Patients must have a life expectancy of 
at least 8 weeks, a Zubrod performance score of 3 or better, and adequate bone 
marrow function (unless inadequate marrow reserve is secondary to tumor 
replacement).  Patients must not have brain metastases, meningeal 
carcinomatosis, or evidence of cardiac dysfunction.

Expected Enrollment

Approximately 70 patients will be required for this study.  Protocol closed 
April 1983.

Outline

Randomized study.
Arm I:  2-Drug Combination Chemotherapy.  Dihydroxyanthracenedione, DHAD, 
NSC-301739 (5-day intermittent iv); Vinblastine, VBL, NSC-49842.
Arm II:  2-Drug Combination Chemotherapy.  DHAD (single-dose iv); VBL.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Eugene M. McKelvey, MD, Protocol chair		Ph: 713-792-2570; 800-392-1611