Lung Cancer Clinical Trial
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
Verified date | April 2013 |
Source | Fox Chase Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | May 2008 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Bon Secours-Holy Family Health System | Altoona | Pennsylvania |
United States | Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
United States | Hunterdon Regional Cancer Center | Flemington | New Jersey |
United States | Pinnacle Health Hospitals | Harrisburg | Pennsylvania |
United States | Conemaugh Memorial Hospital | Johnstown | Pennsylvania |
United States | Kimball Medical Center | Lakewood | New Jersey |
United States | Saint Mary Regional Center | Langhorne | Pennsylvania |
United States | Central Montgomery Medical Center | Lansdale | Pennsylvania |
United States | South Jersey Regional Cancer Center | Millville | New Jersey |
United States | Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly | New Jersey |
United States | Paoli Memorial Hospital | Paoli | Pennsylvania |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Pottstown Memorial Regional Cancer Center | Pottstown | Pennsylvania |
United States | Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | Riverview Medical Center - Booker Cancer Center | Red Bank | New Jersey |
United States | Community Medical Center | Toms River | New Jersey |
United States | St. Francis Medical Center | Trenton | New Jersey |
United States | Southern Chester County Medical Center | West Grove | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Fox Chase Cancer Center | National Cancer Institute (NCI) |
United States,
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