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

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT01693718

Collaborator

(none)

Enrollment

Location

18.1

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Head and Neck	Drug: Hydroxyurea Drug: 5- Fluorouracil Drug: Cisplatin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Sep 1, 2003

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Response Rates [2-5 years]
To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.

Secondary Outcome Measures

Feasibility of administering adjuvant CRA and interferon alfa2a [2-5 years]
To determine the feasibility of administering adjuvant CRA and interferon alfa2a for up to one or until tumor progression in patients completing local therapy.
Side effects of study regimen [2-5 years]
To determine the pattern and degree of clinical toxicity of this regimen

Eligibility Criteria

Criteria

Ages Eligible for Study:

59 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.