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 18 and over NCI DFCI-83084 NCI-T84-0282D, T84-0282

Objectives

I.  Develop an effective multimodal approach to advanced squamous cell 
carcinoma of the head and neck using combination chemotherapy, radiotherapy, 
and surgery.
II.  Compare induction chemotherapy with 
cis-platinum/bleomycin/methotrexate/citrovorum factor vs. 
cis-platinum/5-fluorouracil with respect to disease-free survival, proportion 
of patients eligible for curative therapy, incidence of local control, and 
incidence of distant metastasis.
III.  Compare the antitumor effect of two to four courses of these 
chemotherapeutic regimens in a randomized trial.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients at 
least 18 years of age with histologic documentation of measurable Stage 
II/III/IV squamous cell carcinoma arising in the head and neck that is judged 
to have a less than 50% cure rate based on current survival statistics after 
radiation or surgery; Stage II disease must be in the hypopharynx.  Previously 
treated patients and those with distant metastases (M1) are not eligible.  A 
performance status of 3 or better and adequate renal, hepatic, and hematologic 
function are required.  IVP must be normal if there is any history of 
genitourinary tract or pelvic malignancy.  Patients must have an FEV1 of at 
least 55%, an FEV1/FVC ratio of at least 55%, and a DLCO of greater than 55% 
of the predicted value when corrected for hemoglobin.

Expected Enrollment

An accrual of 173 patients per arm is required; accession is expected to be 
completed in about 2.4 years.

Outline

Randomized study.
Arm I:  3-Drug Combination Chemotherapy with Leucovorin Rescue.  cis-Platinum, 
CACP, NSC-119875; Bleomycin, BLEO, NSC-125066; Methotrexate, MTX, NSC-740; 
Citrovorum Factor, CF, NSC-3590.
Arm II:  2-Drug Combination Chemotherapy.  CACP; 5-Fluorouracil, 5-FU, 
NSC-19893.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

John Clark, MD, Protocol chair(Contact information may not be current)		Ph: 508-383-1240