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

NCT ID: NCT00726986

Last Updated: 2014-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-07-31

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 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.

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.
• 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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sorafenib, Cisplatin, and Etoposide

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

etoposide

Intervention Type: DRUG

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.

sorafenib tosylate

Intervention Type: DRUG

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.

Interventions

cisplatin

Cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Intervention Type: DRUG

etoposide

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.

Intervention Type: DRUG

sorafenib tosylate

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Afshin Dowlati, MD

OTHER

Sponsor Role: lead

Responsible Party

Afshin Dowlati, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Afshin Dowlati, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Nathan Pennell, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Columbia Presbyterian

New York, New York, United States

Lake/University Ireland Cancer Center

Cleveland, Ohio, United States

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

CCF-Fairview Hospital

Cleveland, Ohio, United States

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, United States

Southwest General Health Center

Cleveland, Ohio, United States

UHHS Westlake Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

UH-Monarch

Mayfield Heights, Ohio, United States

UH-Firelands

Sandusky, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE8507

Identifier Type: OTHER

Identifier Source: secondary_id

CASE-8507-CC486

Identifier Type: OTHER

Identifier Source: secondary_id

CASE8507

Identifier Type: -

Identifier Source: org_study_id