Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer
Completed · Phase 2 · Has a placebo group
Conditions studied: Lung Cancer
In brief
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 That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn.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.
Key facts
- Study ID
- NCT00064350
- Run by
- Eastern Cooperative Oncology Group
- People needed
- 342
- Starts
- 2004-06-28
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2023-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 mL/min
- 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
You may not qualify if…
- 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
Where it is running
- Aurora Presbyterian Hospital — Aurora, Colorado, United States
- Boulder Community Hospital — Boulder, Colorado, United States
- Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
- Porter Adventist Hospital — Denver, Colorado, United States
- Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
- St. Joseph Hospital — Denver, Colorado, United States
- Rose Medical Center — Denver, Colorado, United States
- CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
- Swedish Medical Center — Englewood, Colorado, United States
- Front Range Cancer Specialists — Fort Collins, Colorado, United States
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
- Sky Ridge Medical Center — Lone Tree, Colorado, United States
- Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
- St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
- North Suburban Medical Center — Thornton, Colorado, United States
- Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
- Rush-Copley Cancer Care Center — Aurora, Illinois, United States
- St. Joseph Medical Center — Bloomington, Illinois, United States
- Graham Hospital — Canton, Illinois, United States
- Memorial Hospital — Carthage, Illinois, United States
- Decatur Memorial Hospital Cancer Care Institute — Decatur, Illinois, United States
- Alexian Brothers Radiation Oncology — Elk Grove Village, Illinois, United States
- Eureka Community Hospital — Eureka, Illinois, United States
- Galesburg Clinic, PC — Galesburg, Illinois, United States
- Stanford Comprehensive Cancer Center - Stanford — Stanford, California, United States
Full record on ClinicalTrials.gov
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