Clinical trial NCT00726986: Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Official title: Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-08-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free Survival(PFS)
timeFrame: 1-year
Secondary outcomes:
measure: Median Overall Survival
timeFrame: 1-year
measure: Response Rate
timeFrame: reevaluated for response every 8 weeks
measure: Safety
timeFrame: Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Presbyterian
state: New York
city: Cleveland
country: United States
facility: Lake/University Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: CCF-Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: UHHS Chagrin Highlands Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Southwest General Health Center
state: Ohio
city: Cleveland
country: United States
facility: UHHS Westlake Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
city: Mayfield Heights
country: United States
facility: UH-Monarch
state: Ohio
city: Sandusky
country: United States
facility: UH-Firelands
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Afshin Dowlati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Nathan Pennell, MD
role: PRINCIPAL_INVESTIGATOR
References: