Status:
COMPLETED
Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well sorafenib works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by blocking some of t...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer treated with sorafenib. II. Determine the clinical toxic effects of this drug in these...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
- Stage IIIB with pleural effusion
- Stage IV
- Measurable disease
- At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- No known brain metastases, even if treated and stable
- Performance status - ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- No bleeding diathesis
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 3 times ULN (5 times ULN if hepatic metastasis present)
- Creatinine ≤ 1.5 times ULN
- No uncontrolled hypertension
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- HIV negative
- Able to swallow tablets
- No uncontrolled infection
- No other severe underlying disease that would preclude study participation
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas
- No prior immunotherapy, biologic therapy, or gene therapy
- No concurrent prophylactic colony-stimulating factors
- At least 4 weeks since prior low-dose weekly chemotherapy as a radiosensitizer
- No other prior chemotherapy for NSCLC
- No concurrent chemotherapy
- See Chemotherapy
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to ≥ 30% of bone marrow
- No concurrent radiotherapy
- Concurrent palliative radiotherapy to nontarget lesions (e.g., painful pre-existing bony metastasis) allowed
- Prior adjuvant therapy allowed provided recurrent disease occurred \> 6 months after completion of adjuvant therapy
- No prior systemic therapy for NSCLC, including all novel targeted agents (e.g., gefitinib or erlotinib)
- No concurrent therapeutic anticoagulation
- Prophylactic anticoagulation (e.g., low-dose warfarin) for venous and arterial devices allowed provided PT, INR, and PTT requirements are met
- No other concurrent anticancer agents or therapies
- No other concurrent investigational agents or therapies
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00098540
Start Date
December 1 2004
Last Update
December 29 2016
Active Locations (1)
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1
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905