Lung Cancer Clinical Trial

Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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 and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sorafenib together with cisplatin and etoposide works in treating patients with extensive-stage small cell lung cancer.

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Full 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.
To evaluate the 1-year overall survival and response rate in these patients.
To evaluate the safety of these drugs in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral sorafenib tosylate twice daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00726986

Recruitment Status:

Terminated

Sponsor:

Afshin Dowlati, MD

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There are 11 Locations for this study

See Locations Near You

Columbia Presbyterian
New York New York, 10032, United States
Lake/University Ireland Cancer Center
Cleveland Ohio, 44060, United States
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
CCF-Fairview Hospital
Cleveland Ohio, 44111, United States
UHHS Chagrin Highlands Medical Center
Cleveland Ohio, 44122, United States
Southwest General Health Center
Cleveland Ohio, 44130, United States
UHHS Westlake Medical Center
Cleveland Ohio, 44145, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland Ohio, 44195, United States
UH-Monarch
Mayfield Heights Ohio, 44124, United States
UH-Firelands
Sandusky Ohio, 44870, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00726986

Recruitment Status:

Terminated

Sponsor:


Afshin Dowlati, MD

How clear is this clinincal trial information?

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