Status:
TERMINATED
Oxaliplatin, Docetaxel, and Radiation Therapy in Treating Patients With Unresectable Stage II/III or Recurrent NSCLC
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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. Radia...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of oxaliplatin when given with docetaxel and thoracic radiotherapy in patients with unresectable stage II, IIIA, or IIIB or recurrent non-s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00356941
Start Date
April 1 2006
End Date
May 1 2007
Last Update
November 29 2017
Active Locations (1)
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1
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455