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
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: sorafenib tosylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: July 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib, Cisplatin, and Etoposide 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726986

Locations
United States, New York
Columbia Presbyterian
New York, New York, United States, 10032
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
UHHS Westlake Medical Center
Cleveland, Ohio, United States, 44145
Southwest General Health Center
Cleveland, Ohio, United States, 44130
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
CCF-Fairview Hospital
Cleveland, Ohio, United States, 44111
UH-Monarch
Mayfield Heights, Ohio, United States, 44124
UH-Firelands
Sandusky, Ohio, United States, 44870
Sponsors and Collaborators
Afshin Dowlati, MD
Investigators
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
  More Information

No publications provided

Responsible Party: Afshin Dowlati, MD, Principal Investigator, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00726986     History of Changes
Other Study ID Numbers: CASE8507, P30CA043703, CASE8507, CASE-8507-CC486
Study First Received: July 31, 2008
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Sorafenib
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 10, 2014