RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may make tumor cells more sensitive to radiation therapy. PURPOSE: Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation therapy followed by filgrastim in treating patients who have recurrent head and neck cancer or lung cancer.

Condition	Treatment or Intervention	Phase
Lung Cancer Salivary Gland Cancer lip and oral cavity cancer Head and Neck Cancer Thyroid Cancer Oropharyngeal Cancer	Procedure: chemotherapy  Procedure: biological response modifier therapy  Procedure: radiation therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Drug: cisplatin  Drug: filgrastim  Drug: paclitaxel	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response rate of patients with locally recurrent carcinoma of the head and neck or lung treated with paclitaxel and cisplatin with concurrent radiotherapy followed by filgrastim (G-CSF). II. Assess the toxicity of this regimen in these patients. III. Determine the time to progression and the sites and pattern of progression in patients treated with this regimen. IV. Determine the median, 1-year, and 2-year survival rates of patients treated with this regimen.

PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to disease (squamous cell carcinoma of the head and neck vs salivary gland malignancy or other non-squamous cell carcinoma of the head and neck vs lung cancer). Patients receive paclitaxel IV over 1 hour and cisplatin IV over 30-120 minutes on days 1-5. Patients undergo radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously on days 6-13 or until blood counts recover. Treatment repeats every 2 weeks for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 42-84 patients (14-28 per stratum) will be accrued for this study within 2-4 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of 1 of the following: Previously irradiated, locally recurrent squamous cell carcinoma of the head and neck (SCCHN) or head and neck skin/appendages with no distant metastases; New second or subsequent primary SCCHN in a previously irradiated field with no distant metastases; Salivary gland malignancy or other non-squamous cell primary head and neck cancer; Previously irradiated, locally recurrent carcinoma of the lung
• No clinical evidence of symptomatic bone or brain metastases requiring radiotherapy
• No leptomeningeal metastases requiring intrathecal therapy

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 4 weeks since prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; At least 3 months since prior radiotherapy; Prior or concurrent cumulative radiotherapy dose to spinal cord no greater than 5,000 cGy
• Surgery: Not specified
• Other: Concurrent beta-blockers, digitalis derivatives, or calcium-channel blocking agents allowed if cardiac conditions are stable

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT no greater than 3 times upper limit of normal
• Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
• Cardiovascular: No active, uncontrolled congestive heart failure or arrhythmia within the past 6 months
• Other: No pre-existing neuropathy grade 2 or greater interfering with daily activities; No prior allergy to drugs using Cremophor EL; No hypersensitivity to E. coli-derived proteins; No significant concurrent medical or psychiatric disorder that would preclude study; No other condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for at least 3 months after study

New Jersey
      Community Medical Center, Toms River,  New Jersey,  08755,  United States
      Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly,  New Jersey,  08060,  United States
      Hunterdon Regional Cancer Center, Flemington,  New Jersey,  08822,  United States
      Kimball Medical Center, Lakewood,  New Jersey,  08701,  United States
      Riverview Medical Center - Booker Cancer Center, Red Bank,  New Jersey,  07701,  United States
      South Jersey Regional Cancer Center, Millville,  New Jersey,  08332,  United States
      St. Francis Medical Center, Trenton,  New Jersey,  08629,  United States
Pennsylvania
      Bon Secours-Holy Family Health System, Altoona,  Pennsylvania,  16602,  United States
      Central Montgomery Medical Center, Lansdale,  Pennsylvania,  19446-1200,  United States
      Conemaugh Memorial Hospital, Johnstown,  Pennsylvania,  15905,  United States
      Delaware County Memorial Hospital, Drexel Hill,  Pennsylvania,  19026,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      Paoli Memorial Hospital, Paoli,  Pennsylvania,  19301-1792,  United States
      Pinnacle Health Hospitals, Harrisburg,  Pennsylvania,  17105-8700,  United States
      Pottstown Memorial Regional Cancer Center, Pottstown,  Pennsylvania,  19464,  United States
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States
      Saint Mary Regional Center, Langhorne,  Pennsylvania,  19047,  United States
      Southern Chester County Medical Center, West Grove,  Pennsylvania,  19390,  United States

Study chairs or principal investigators

Corey Jay Langer,  Study Chair,  Fox Chase Cancer Center   

Study ID Numbers:  CDR0000068770; FCCC-99025; NCI-G01-1983
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00021333
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08