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A Double Blind Phase II Study of BAY 43-9006 in Patients With Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.

Date & Status


Who can Participate?


18 and older



Inclusion Criteria:

- Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC)

- Disease must have progressed after at least 2 prior chemotherapy regimens for NSCLC

- Patients must have measurable or nonmeasurable disease

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 3 times ULN (5 times ULN in patients with liver disease)

- Creatinine less than 1.5 times ULN or calculated creatinine clearance greater than 50

- More than 3 weeks since prior chemotherapy, radiotherapy, immunotherapy or other
investigational drug use

- Recovered from all prior therapy

- Fertile patients must use effective contraception

- Age >= 18

- ECOG performance status of 0-1

Exclusion Criteria:

- Prior primary or metastatic brain or meningeal tumors unless clinically and
radiographically stable and off therapy for at least 2 months

- Active second malignancy

- Clinically evident congestive heart failure, serious cardiac arrhythmias, or symptoms
of coronary heart disease

- Prior radiotherapy to the only site of measurable or evaluable disease unless there
is evidence of disease progression in that site

- Prior exposure to a ras pathway inhibitor (e.g., farnesyl transferase inhibitor)

- Concurrent medications known to be metabolized by the liver with a narrow therapeutic
index, including the following:

- Ketoconazole

- Itraconazole

- Quinidine

- Digoxin

- Cyclosporine

- Ritonavir

- Grapefruit products

- Carbamazepine

- Phenytoin

- Phenobarbital

- Pregnant or nursing

- Clinically serious active infection

- Medical conditions, substance abuse or psychological/social situation that would
preclude study participation

Gender: Both
Steward Physician(s)
  • Joan H. Schiller, MD
  • William A. Flood, MD
  • Morton Hospital - Completed
Trial Interventions
  • Sorafenib
  • Placebo
Physician Researcher

Investigator Name:

  • Joan H. Schiller, MD
  • William A. Flood, MD

Other Information

Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 2
Trial ID: NCT00064350
Volunteers:  Not Accepting Healthy Volunteers

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