Status:
COMPLETED
Erlotinib, Paclitaxel, and Carboplatin Combined With Radiation Therapy for Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Nathan Pennell, MD, PhD
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways t...
Detailed Description
OBJECTIVES: Primary * Assess the safety and feasibility of erlotinib hydrochloride, paclitaxel, and carboplatin in combination with accelerated hyperfractionated radiotherapy in patients with stage ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Surgically determined stage IIIA or IIIB disease
- Histology from an involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs
- Histological or cytological proof of mediastinal nodal involvement by mediastinoscopy, Chamberlain procedure, thoracoscopy, thoracotomy, or CT-guided biopsy is required except for cases of paralysis of left true vocal cord with separate left lung primary distinct from enlarged nodes \> 1 cm in the anterior-posterior window seen on the CT scan
- Patients with N3 or T4 status must be evaluated and deemed potentially resectable after induction chemotherapy and radiation therapy
- Measurable and evaluable disease
- No malignant pleural effusion except for effusion visible only on CT scan and deemed too small to tap
- No pericardial effusion
- No small or mixed small cell/non-small cell lung cancer
- No massive lesions requiring radiation to the entire lung
- No metastatic cancer to the lungs
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Serum creatinine ≤ 2.0 mg/dL
- Alkaline phosphatase, AST, and ALT \< 2 times upper limit of normal
- Albumin \> 3.0 g/dL
- Serum bilirubin \< 1.5 mg/dL
- Adequate pulmonary function
- No clinical evidence of another uncontrolled malignancy
- No requirement for urgent therapy for severe local symptoms such as post-obstructive pneumonia
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiation therapy, or immunotherapy for lung cancer
- No prior surgery to treat the cancer
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00278148
Start Date
October 1 2005
End Date
February 1 2011
Last Update
July 20 2020
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195