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| Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00021333 |
Purpose
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 | Intervention | Phase |
|
Head and Neck Cancer Lung Cancer |
Drug: cisplatin Drug: filgrastim Drug: paclitaxel Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Lung Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Evaluation Of Paclitaxel And Cisplatin In Combination With Split Course Hyperfractionated Radiation Therapy And Granulocyte-Colony Stimulating Factor In Previously Irradiated Patients With Locally Recurrent Carcinoma Of The Head And Neck, And Lung |
| Study Start Date: | September 1999 |
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.
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
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
Contacts and Locations| United States, New Jersey | |||||
| Community Medical Center | |||||
| Toms River, New Jersey, United States, 08755 | |||||
| Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | |||||
| Mount Holly, New Jersey, United States, 08060 | |||||
| Hunterdon Regional Cancer Center | |||||
| Flemington, New Jersey, United States, 08822 | |||||
| St. Francis Medical Center | |||||
| Trenton, New Jersey, United States, 08629 | |||||
| Riverview Medical Center - Booker Cancer Center | |||||
| Red Bank, New Jersey, United States, 07701 | |||||
| South Jersey Regional Cancer Center | |||||
| Millville, New Jersey, United States, 08332 | |||||
| Kimball Medical Center | |||||
| Lakewood, New Jersey, United States, 08701 | |||||
| United States, Pennsylvania | |||||
| Bon Secours-Holy Family Health System | |||||
| Altoona, Pennsylvania, United States, 16602 | |||||
| Central Montgomery Medical Center | |||||
| Lansdale, Pennsylvania, United States, 19446-1200 | |||||
| Southern Chester County Medical Center | |||||
| West Grove, Pennsylvania, United States, 19390 | |||||
| Delaware County Memorial Hospital | |||||
| Drexel Hill, Pennsylvania, United States, 19026 | |||||
| Fox Chase Cancer Center | |||||
| Philadelphia, Pennsylvania, United States, 19111 | |||||
| Paoli Memorial Hospital | |||||
| Paoli, Pennsylvania, United States, 19301-1792 | |||||
| Pinnacle Health Hospitals | |||||
| Harrisburg, Pennsylvania, United States, 17105-8700 | |||||
| Pottstown Memorial Regional Cancer Center | |||||
| Pottstown, Pennsylvania, United States, 19464 | |||||
| Reading Hospital and Medical Center | |||||
| Reading, Pennsylvania, United States, 19612-6052 | |||||
| Saint Mary Regional Center | |||||
| Langhorne, Pennsylvania, United States, 19047 | |||||
| Conemaugh Memorial Hospital | |||||
| Johnstown, Pennsylvania, United States, 15905 | |||||
| Fox Chase Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Corey J. Langer, MD | Fox Chase Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068770, FCCC-99025, NCI-G01-1983 |
| First Received: | July 11, 2001 |
| Last Updated: | October 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00021333 |
| Health Authority: | United States: Federal Government |
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