Oxaliplatin, Docetaxel, and Radiation Therapy in Treating Patients With Unresectable Stage II/III or Recurrent NSCLC

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and docetaxel together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when given together with docetaxel and radiation therapy in treating patients with unresectable stage II or stage III or recurrent non-small cell lung cancer .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Docetaxel; Oxaliplatin

Criteria

Inclusion Criteria:

• Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

• Medically inoperable or unresectable stage II, IIIA, or IIIB disease

• Post-resection intrathoracic tumor recurrence

• Measurable disease by computed tomography(CT) scan

• No evidence of small cell histology

• No significant pleural effusion on chest x-ray or malignant pleural effusion on cytology

• No metastatic disease

• Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

• Absolute granulocyte count ≥ 2,000/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 8.0 g/dL

• Bilirubin ≤ 1.5 mg/dL

• Serum glutamic oxaloacetic transaminase (SGOT) ≤ 1.5 times upper limit of normal (unless abnormality is caused by documented benign disease)

• Creatinine ≤ 1.5 mg/dL

• Weight loss ≤ 10% within the past 3 months

• Forced expiratory volume (FEV) 1 ≥ 1,000 cc

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

Exclusion Criteria:

• Synchronous (except for nonmelanomatous skin cancer) or prior invasive malignancy, unless disease free for > 3 years

• Myocardial infarction within the past 6 months

• Symptomatic heart disease, including any of the following:

• Angina

• Congestive heart failure

• Uncontrolled arrhythmia

• Active infection or fever ≥ 38.5°C within the past 3 days

• Known hypersensitivity to any of the components of oxaliplatin or docetaxel

• Prior thoracic or neck radiotherapy

• Prior docetaxel or oxaliplatin