Overview

Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer

Status:
Completed
Trial end date:
2008-05-01
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. 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fox Chase Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Lenograstim
Paclitaxel
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

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