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Phase II/III cis-Platinum in 2-Drug and 3-Drug Combinations with VP-16 and DAVA for Advanced non-Oat Cell Carcinoma of the Lung

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-8075
NCI-D81-043-098

Objectives

I.  Determine the efficacy of three combinations of chemotherapy in patients 
with extensive non-oat cell lung cancer.  The combinations are 
VP-16/vindesine/cis-platinum, VP-16/cis-platinum, and vindesine/cis-platinum.
II.  Determine the qualitative and quantitative toxicities of these three 
chemotherapy combinations.
III.  Study and compare the response rates and duration of survival in 
patients with extensive non-oat cell lung cancer treated by these three 
chemotherapy combinations.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable, 
histologically proven, metastatic non-oat cell carcinoma, who have received no 
prior chemotherapy, and no radiotherapy or surgery unless there is evidence of 
subsequent disease progression.  Patients must have a life expectancy of at 
least 12 weeks and have adequate hematologic, hepatic, and renal function.

Expected Enrollment

100 patients (approximately 33 per treatment arm) will be entered over 12-18 
months.  Protocol closed February 1983.

Outline

Randomized study.
Arm I:  3-Drug Combination Chemotherapy.  cis-Platinum, CACP, NSC-119875; 
Vindesine, DAVA, NSC-245467; VP-16213, VP-16, NSC-141540.
Arm II:  2-Drug Combination Chemotherapy.  CACP; VP-16.
Arm III:  2-Drug Combination Chemotherapy.  CACP; DAVA.

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

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.