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 Treatment Completed 21 to 69 NCI CLB-8084 CALGB-8084

Objectives

I.  Determine whether the addition of warfarin to MACC 
(methotrexate/adriamycin/CCNU/cyclophosphamide) chemotherapy will prolong the 
disease-control interval (as measured from the start of protocol to the first 
documented disease progression) when compared to MACC alone.
II.  Compare these two regimens with respect to objective response 
frequencies, remission duration, and survival duration.
III.  Determine whether alternating MEPH 
(mitomycin-C/VP-16213/cisplatin/hexamethylmelamine) and MACC chemotherapy will 
increase the objective response frequency, remission duration, and length of 
survival when compared to MACC alone.
IV.  Compare these two regimens with respect to initial response frequency 
after the first cycle of MEPH versus the first cycle of MACC.
V.  Evaluate the levels of neurophysins before, during, and after therapy in 
patients with extensive small cell lung cancer, and correlate response and 
survival with neurophysin levels.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients older than 20 and younger 
than 70 years of age with clinically demonstrable, measurable small cell lung 
cancer that extends beyond the lung and ipsilateral or contralateral hilar and 
supraclavicular lymph nodes.  There may have been no prior chemotherapy and 2 
to 3 weeks must have elapsed since prior radiotherapy.  There may be no other 
concomitant malignant tumor or prior history of a second primary neoplasm 
(except curatively treated skin cancer or surgically cured in situ carcinoma 
of the cervix) and no active infection.  Patients must have adequate 
hematologic, renal, hepatic, and cardiac function and a performance status of 
better than 4.  Pregnancy and any contraindication for the use of warfarin 
exclude.

Expected Enrollment

270 patients will be required, with an expected accrual time of 39 months.  
Protocol closed June 1984 with accrual goals met.

Outline

Randomized study.
Arm I:  4-Drug Combination Chemotherapy.  MACC:  Methotrexate, MTX, NSC-740; 
Adriamycin, ADR, NSC-123127; CCNU, NSC-79037; Cyclophosphamide, CTX, NSC-26271.
Arm II:  5-Drug Combination Chemotherapy.  MACC; Warfarin, NSC-59813.
Arm III:  Two Alternating 4-Drug Combination Chemotherapies.  MACC; and MEPH:  
Mitomycin-C, MITO, NSC-26980; Etoposide, VP-16, NSC-141540; cis-Platinum, 
Cisplatin, CACP, NSC-119875; Hexamethylmelamine, HMM, NSC-13875.

Chahinian AP, Ware JH, Zimmer B, et al.: Update on anticoagulation with warfarin and on alternating chemotherapy in extensive small cell cancer of the lung (SCCL). [Abstract] Proceedings of the American Society of Clinical Oncology 4: C-748, 191, 1985.

North WG, Ware J, Maurer LH, et al.: Neurophysins as tumor markers for small cell carcinoma of the lung. A cancer and Leukemia Group B evaluation. Cancer 62 (7): 1343-7, 1988.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Emil Frei, MD, Protocol chair(Contact information may not be current)		Ph: 773-702-9171