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

This study has been terminated.
(Extreme toxicity)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Afshin Dowlati, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00726986
First received: July 31, 2008
Last updated: April 17, 2013
Last verified: February 2013

July 31, 2008
April 17, 2013
July 2008
July 2012   (final data collection date for primary outcome measure)
  • progression-free survival [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: reevaluated for response every 8 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity. ] [ Designated as safety issue: Yes ]
  • 1-year progression-free survival [ Designated as safety issue: No ]
  • 1-year overall survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00726986 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: 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.
  • 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.
  • 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.
Experimental: Sorafenib, Cisplatin, and Etoposide
Interventions:
  • Drug: cisplatin
  • Drug: etoposide
  • Drug: sorafenib tosylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00726986
CASE8507, P30CA043703, CASE8507, CASE-8507-CC486
Yes
Afshin Dowlati, MD, Case Comprehensive Cancer Center
Afshin Dowlati, MD
National Cancer Institute (NCI)
Principal Investigator: Afshin Dowlati, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Principal Investigator: Nathan Pennell, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP