Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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 the enzymes needed for cell growth. It may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor.
Checked against the public recordLast updated Dec 29, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- National Cancer Institute (NCI)
- Interventions being studied
- Drug: sorafenib tosylate; Other: laboratory biomarker analysis
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- North Central Cancer Treatment GroupRochester, Minnesota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 29, 2016. Always confirm current availability with the study team.