Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
This study has been terminated.
(Extreme toxicity)
Sponsor:
Afshin Dowlati, MD
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
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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:
Drug Information available for:
Cisplatin
Etoposide
Etoposide phosphate
Sorafenib
Sorafenib tosylate
U.S. FDA Resources
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
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
Additional 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 May 16, 2013