Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer

Launched by VANDERBILT-INGRAM CANCER CENTER · Apr 21, 2004

Keywords

ClinConnect Summary

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of paclitaxel when combined with standard thoracic radiotherapy in patients with locally advanced non-small cell lung cancer. II. Determine the plasma levels of paclitaxel in these patients. III. Determine the effect of this regimen on the tumor cell cycle distribution in these patients.

OUTLINE: This is a dose-escalation study of paclitaxel. Patients undergo standard thoracic radiotherapy 5 days a week for 7 weeks. Patients receive paclitaxel IV continuously beginning 48 hours before initiating radiotherapy and continuing un...

Gender

ALL

Eligibility criteria

• • DISEASE CHARACTERISTICS: Histologically proven previously untreated non-small cell lung cancer that is not amenable to potentially curative surgery due to the following: Direct invasion of the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina by tumor (T4) Cytologically positive scalene or supraclavicular nodes Mediastinal or contralateral hilar nodes 3 cm or greater on CT, with or without pathological confirmation Pathologically positive mediastinal or contralateral hilar nodes on mediastinoscopy or Chamberlain procedure (N2 or N3) Medically inoperable stage IIIA disease (e.g., resection would result in insufficient pulmonary volume) allowed No distant metastases No pleural effusion (regardless of fluid cytology) Evaluable disease
• • PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Hematopoietic: WBC normal Platelet count normal Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Transaminases no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No significant coronary artery disease No documented myocardial infarction No angina, arrhythmia, or congestive heart failure requiring medication Pulmonary: FEV1 greater than 1 liter pO2 greater than 55 mm Hg on room air pCO2 less than 45 mm Hg on room air Other: No prior severe hypersensitivity reaction to products containing Cremaphor EL No clinical evidence of pre-existing polyneuropathy Not pregnant Negative pregnancy test
• • PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic irradiation Surgery: See Disease Characteristics Other: No concurrent medications known to alter cardiac conduction or cause bradycardia (e.g., digoxin, beta blockers, or calcium channel blockers)

Trial Officials