Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Niacinamide; Sorafenib

Criteria

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