Status:
TERMINATED
Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Afshin Dowlati, MD
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin an...
Detailed Description
OBJECTIVES: * To evaluate the 1-year progression-free survival of patients with extensive-stage small cell lung cancer treated with sorafenib tosylate in combination with cisplatin and etoposide. * T...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of extensive-stage small cell lung cancer
- No untreated brain metastases
- No active symptoms related to brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Hemoglobin ≥ 9.0 g/dL
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
- Creatinine ≤ 1.5 times ULN
- INR \< 1.5 or PT/PTT normal
- No history of cardiac disease, including any of the following:
- NYHA class III-IV congestive heart failure
- Unstable angina (i.e., anginal symptoms at rest)
- Onset of angina within the past 3 months
- Myocardial infarction within the past 6 months
- No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite optimal medical management
- No thrombolic or embolic events, such as cerebrovascular accident or transient ischemic attacks, within the past 6 months
- No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
- No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
- No known HIV infection or chronic hepatitis B or C infection
- No active clinically serious infection \> CTCAE grade 2
- No serious non-healing wound, ulcer, or bone fracture
- No evidence or history of bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 4 weeks
- No known or suspected allergy to sorafenib tosylate or to any other drug given during the study
- No condition that would impair the patient's ability to swallow whole pills
- No known malabsorption problem
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- Male patients must use effective contraception during and for ≥ 3 months after completion of sorafenib tosylate
- PRIOR CONCURRENT THERAPY:
- Prior radiotherapy to the brain allowed
- No prior chemotherapy
- More than 4 weeks since prior major surgery or open biopsy
- No concurrent Hypericum perforatum (St. John's wort) or rifampin
- Concurrent anti-coagulation treatment, such as warfarin or heparin, allowed
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00726986
Start Date
July 1 2008
End Date
July 1 2012
Last Update
November 19 2014
Active Locations (11)
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1
Columbia Presbyterian
New York, New York, United States, 10032
2
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
3
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
4
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109