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 no age specified MDA-DT-8102

Objectives

I.  Evaluate the efficacy and toxicities of CAP 
(cyclophosphamide/adriamycin/cis-platinum) in inoperable non-small cell lung 
cancer patients and compare 2 different iv schedules for ADR administration:  
a 24-hour continuous infusion q 3 weeks vs. weekly 30-minute infusions.
II.  Correlate clinical noninvasive techniques of cardiac toxicity with that 
of endomyocardial biopsies in patients treated with these regimens.
III.  Establish anatomicopathologic correlations between striated muscle 
biopsy and endomyocardial biopsy in these patients.
IV.  Evaluate the potential additive cardiotoxic effect of chest irradiation 
administered to patients with limited disease treated with either of these 
regimens.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologic proof of 
inoperable non-small cell lung cancer, with limited or extensive disease, 
whose performance status is 0 or 1.  Stage III NED patients after surgery or 
radiotherapy are eligible.  There may have been no prior chemotherapy, and 
patients may not have brain metastases.  Patients must have been off all prior 
therapy for at least 4 weeks and must have recovered from toxic effects of 
prior treatment.  Hepatic, renal, and hematopoietic function must be adequate.

Expected Enrollment

100 patients will be entered over a 2-year period.  Protocol closed.

Outline

Patients are randomized to Arms I and II.  Following treatment on Arm I or Arm 
II, patients with limited disease are randomized to Arms III and IV.
Arm I:  3-Drug Combination Chemotherapy.  CAP:  Cyclophosphamide, CTX, 
NSC-26271; Adriamycin, ADR, NSC-123127; cis-Platinum, CACP, NSC-119875.  ADR 
on a q-3-weeks schedule; patients with endomyocardial toxicity on ADR 
discontinue ADR and receive Methotrexate, MTX, NSC-740.
Arm II:  3-Drug Combination Chemotherapy.  CAP:  CTX; ADR; CACP.  ADR given on 
a weekly schedule; patients with endomyocardial toxicity on ADR discontinue 
ADR and receive MTX.
Arm III:  Radiotherapy.  Irradiation of the primary lesion plus prophylactic 
brain irradiation.
Arm IV:  Radiotherapy.  Irradiation of the primary lesion.

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