A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer

The University of Chicago

Status and phase

Completed

Phase 2

Conditions

Head and Neck

Treatments

Drug: Hydroxyurea

Drug: 5- Fluorouracil

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

12141B

Details and patient eligibility

About

The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.

Enrollment

44 patients

Sex

All

Ages

59+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

Patients with Stage IV carcinoma of the nasal or oral cavity, nasopharynx pharynx, larynx, paranasal sinuses, cervical esophagus, or hypopharynx are eligible. Patients with Stage III carcinoma of the nasopharynx, base of tongue and hypopharynx are also eligible. Therapy is given with curative intent.

Prior to entry in the study the resectability and standard treatment options for each patient will be determined during a joint evaluation by a team composed of an attending surgeon, a radiation oncologist and a medical oncologist. In addition the timing and feasibility of surgery will be determined in each patient prior to initiation of therapy. The unequivocal demonstration of distant metastasis confers in eligibility.
Measurable disease is not required, but all disease will be carefully evaluated.
Patients must have a histologically or cytologically confirmed diagnosis of squamous cell carcinoma or lymphoepithelioma.
Patients must have not received prior chemotherapy or radiotherapy.
Patients must have performance status of >60%
Patients must have a WBC count of >3.5, an ANC count >1500 and a platlet count of >100,000.
The serum creatinine must be equal to or less than 1.5 m/dlor the calculated creatinine clearance must exceed 50cc/min.
Patient must be free of significant infection or other severe complicating medical illness.
Pregnancy will constitute an absolute contraindication to entrance on this protocol. Females of child-bearing age should be using adequate contraception.