Overview

Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin alone for metastatic or recurrent head and neck cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin with or without monoclonal antibody in treating patients who have metastatic or recurrent head and neck cancer.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator:

National Cancer Institute (NCI)

Treatments:

Antibodies
Antibodies, Monoclonal
Cetuximab
Cisplatin

Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck
that is incurable with surgery or radiotherapy No nasopharyngeal primaries Measurable or
evaluable disease Newly diagnosed with extensive, incurable local regional disease AND
distant metastases OR Local regional recurrence/persistence or distant metastases after
surgery or radiotherapy Persistent or progressive disease after radiotherapy must be
histologically proven at least 8 weeks after therapy No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin no
greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.2
mg/dL OR Creatinine clearance at least 50 mL/min Calcium no greater than ULN No history of
hypercalcemia Other: No active infection No other concurrent malignancy within past 2 years
except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of
the cervix No known hypersensitivity to murine proteins Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior chimeric antibody or kinase inhibitor
for recurrent or metastatic disease No more than 1 prior biotherapy regimen for recurrent
or metastatic disease Chemotherapy: At least 3 months since prior induction or adjuvant
chemotherapy concurrent with radiotherapy No prior chemotherapy for recurrent disease
Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks
since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior major
surgery