Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Completed	no age specified	NCI	EST-1583

Objectives

I.  Compare response rates, time to progression, and survival of patients with 
metastatic non-small cell lung cancer treated with MVP 
(mitomycin-C/vinblastine/cis-platinum) vs. CHIP vs. CBDCA vs. 
vinblastine/cis-platinum vs. MVP-CAMP 
(mitomycin-C/vinblastine/cis-platinum/cyclophosphamide/adriamycin/ 
methotrexate/procarbazine).
II.  Compare the toxicities of these chemotherapeutic regimens.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable or evaluable 
non-small cell bronchogenic carcinoma histologically confirmed on cytologic 
specimens obtained by brushing, washing, or needle aspiration of a defined 
lesion, provided they have Stage III M1 disease and have not received prior 
chemotherapy.  Ipsilateral intrathoracic nodal disease does not qualify as 
sole evidence of metastatic disease.  Liver, kidney, and bone marrow function 
must be adequate, and the performance status must be 0-2.  There may be no 
prior uncontrolled malignancy, except skin cancer, but patients with prior 
malignancies controlled for more than 5 years may be eligible.  Patients with 
prior radiotherapy must demonstrate progression in previously irradiated sites 
or have measurable or evaluable disease outside previous radiation ports.  
Patients must be free of uncontrolled infection and may not have brain 
metastases.  Patients must be free of cardiac disease, including uncontrolled 
hypertension, unstable angina, congestive heart failure, and myocardial 
infarction within 1 year.

Expected Enrollment

150 patients will be entered on each arm over about 2 years.  As per Addendum 
1, February 1985, Arms II and III are closed to patient entry, having met 
accrual limits.  Protocol closed July 1985.

Outline

Randomized study.
Arm I:  3-Drug Combination Chemotherapy.  MVP:  Mitomycin-C, MITO, NSC-26980; 
Vinblastine, VBL, NSC-49842; cis-Platinum, CACP, NSC-119875.
Arm II:  Single-agent Chemotherapy.  Platinum IV, CHIP, NSC-256927.  As per 
Addendum 1, February 1985, Arm II is closed to patient entry, having met 
accrual limits.
Arm III:  Single-agent Chemotherapy.  Carboplatin, CBDCA, NSC-241240.  As per 
Addendum 1, February 1985, Arm III is closed to patient entry, having met 
accrual limits.
Arm IV:  2-Drug Combination Chemotherapy.  VBL; CACP.
Arm V:  7-Drug Combination Chemotherapy.  MVP-CAMP:  MITO; VBL; CACP; 
Cyclophosphamide, CTX, NSC-26271; Adriamycin, ADR, NSC-123127; Methotrexate, 
MTX, NSC-740; Procarbazine, PCB, NSC-77213.

Belani C, Kim K, Bonomi PD, et al.: Retrospective estimation of carboplatin exposure by Calvert's and Chatelut's formulae and correlation with pharmacodynamic effects in metastatic non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 15: A1119, 1996.

Bonomi PD, Finkelstein DM, Ruckdeschel JC, et al.: Combination chemotherapy versus single agents followed by combination chemotherapy in stage IV non-small-cell lung cancer: a study of the Eastern Cooperative Oncology Group. J Clin Oncol 7 (11): 1602-13, 1989.[PUBMED Abstract]

Bonomi P, Mehta C, Ruckdeschel J, et al.: Phase II-III trial of mitomycin-vinblastine-cisplatin (MVP); vinblastine-cisplatin (VP); MVP alternating with cyclophosphamide adriamycin-methotrexate-procarbazine (MVP/CAMP); CBDCA followed by MVP; and CHIP followed by MVP in patients with metastatic non-small cell lung cancer (NSCLC): an ECOG study . [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-699, 177, 1987.

Jiroutek M, Johnson DH, Blum RH, et al.: Prognostic factors in advanced non-small cell lung cancer (NSCLC): analysis of Eastern Cooperative Oncology Group (ECOG) Trials from 1981-1992. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1774, 461a, 1998.

Kim K, Ettinger D, Bonomi P, et al.: Treatment effects on survival within gender and race subgroups in lung cancer: ECOG's experience. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1101, 360, 1995.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Philip Bonomi, MD, Protocol chair		Ph: 312-942-8312 Email: Philip_Bonomi@rsh.net