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

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Radiation: radiation therapy; Biological: filgrastim; Procedure: conventional surgery; Drug: paclitaxel; Drug: cisplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00005087

CDR0000067705

RTOG-9911

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the median, one-year, and long-term (defined as two-year) disease-free survival and overall survival in patients with previously irradiated locally recurrent squamous cell cancer of the head and neck treated with paclitaxel, cisplatin, and filgrastim (G-CSF) combined with radiotherapy.
• Determine the rates of acute and late toxic effects of this regimen in these patients.
• Determine the pattern of disease progression in patients treated with this regimen.

OUTLINE: Patients undergo radiotherapy twice daily (4-6 hours apart) on days 1-5. Patients receive paclitaxel IV over 1 hour beginning immediately after completion of the first fraction of radiotherapy and completing less than 3 hours before starting the second fraction of radiotherapy on days 1-5. Patients receive cisplatin IV over 30 minutes beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim (G-CSF) subcutaneously on days 6-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who initially respond to therapy but develop a recurrence with a resectable lesion (inside or outside the retreatment field) may undergo surgical resection.

Patients are followed at 4 weeks after completion of radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 34 months.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Radiation (BID) and chemotherapy

Experimental group

Description:

Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13.

Treatment:

Procedure: conventional surgery

Drug: paclitaxel

Drug: cisplatin

Biological: filgrastim

Radiation: radiation therapy