Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim combined with radiation therapy in treating patients who have locally recurrent head and neck cancer and have received previous treatment with radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Lenograstim; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven locally recurrent primary squamous cell cancer (SCC) of the head and neck or second primary SCC of the head and neck

• More than 1 prior recurrence allowed if the first recurrence occurred at least 6 months after completion of prior radiotherapy

• Disease must be confined to the head and neck (above the clavicles)

• No primary SCC of the nasopharynx or salivary gland

• Prior irradiation of 45-75 Gy to the majority (75% or greater) of tumor volume

• Entire tumor volume must be included in a treatment field that limits the total spinal cord dose (prior and anticipated) to 50 Gy

• Prior radiotherapy records, including simulation and portal films, available in order to assure that cord tolerance is not exceeded

• Measurable disease

• Ineligible for complete surgical resection

• No distant metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0 or 1

Life expectancy:

• No other concurrent illness that would limit survival

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 2 times normal*

• Alkaline phosphatase no greater than 2 times normal*

• * Greater than 2 times normal allowed if no metastases by liver ultrasound or CT scan

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• No other invasive malignancy within the past 2 years except in situ malignancies (e.g., carcinoma in situ of the cervix, carcinoma in situ of the breast, or nonmelanoma skin cancer)

• No other concurrent illness that would impair tolerance to therapy

• No grade 2 or worse pre-existing peripheral sensory neuropathy

• No hypersensitivity to E. coli derived products

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior chemotherapy allowed as a component of the primary treatment

• No prior chemotherapy for recurrent disease

• At least 6 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 6 months since prior radiotherapy

Surgery:

• See Disease Characteristics