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

Phase 2

Terminated

• Conditions: Lung Cancer
• Interventions: Drug: cisplatin; Drug: etoposide; Drug: sorafenib tosylate

• Registration Number: NCT00726986
• Lead Sponsor: Afshin Dowlati, MD

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2014-07-08
• Results First Submitted QC: 2014-07-08
• Results First Posted: 2014-08-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib, Cisplatin, and Etoposide	sorafenib tosylate	-
Sorafenib, Cisplatin, and Etoposide	etoposide	-
Sorafenib, Cisplatin, and Etoposide	cisplatin	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival(PFS)	1-year	PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

Secondary Outcome Measures

Name	Time	Method
Response Rate	reevaluated for response every 8 weeks	The Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess response to the treatment.; Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Median Overall Survival	1-year	Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.
Safety	Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.	Number of patients that experienced grade 3-4-5 treatment related toxicities. Toxicity was graded by the National Cancer Institute Common Terminology Criteria version 3.0.

Trial Locations

Locations (11)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

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

CCF-Fairview Hospital; 🇺🇸 Cleveland, Ohio, United States

UHHS Chagrin Highlands Medical Center; 🇺🇸 Cleveland, Ohio, United States

Southwest General Health Center; 🇺🇸 Cleveland, Ohio, United States

UH-Monarch; 🇺🇸 Mayfield Heights, Ohio, United States

UHHS Westlake Medical Center; 🇺🇸 Cleveland, Ohio, United States

UH-Firelands; 🇺🇸 Sandusky, Ohio, United States