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CompletedPhase 2NCT00098540
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedsorafenib tosylate and laboratory biomarker analysis

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 29, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

04
Study sites

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.

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