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

NCT00726986 | Terminated Phase 2 Results DMC

• 3 other identifiers: CASE8507P30CA043703CASE-8507-CC486
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 11

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.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival(PFS)

  PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

  1-year

Secondary Outcomes (3)

• Median Overall Survival

  1-year

• Response Rate

  reevaluated for response every 8 weeks

• Safety

  Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.

Study Arms (1)

Sorafenib, Cisplatin, and Etoposide

EXPERIMENTAL

Drug: cisplatin; Drug: etoposide; Drug: sorafenib tosylate

Interventions

cisplatin DRUG

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.

Sorafenib, Cisplatin, and Etoposide

etoposide DRUG

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.

Sorafenib, Cisplatin, and Etoposide

sorafenib tosylate DRUG

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.

Sorafenib, Cisplatin, and Etoposide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Afshin Dowlati, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Columbia Presbyterian

New York, New York, 10032, United States

Location

Lake/University Ireland Cancer Center

Cleveland, Ohio, 44060, United States

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

CCF-Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

Southwest General Health Center

Cleveland, Ohio, 44130, United States

Location

UHHS Westlake Medical Center

Cleveland, Ohio, 44145, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

UH-Monarch

Mayfield Heights, Ohio, 44124, United States

Location

UH-Firelands

Sandusky, Ohio, 44870, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Etoposide; Sorafenib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

This study was terminated after enrolling 18 patients on the basis of excessive toxicity observed and preliminary efficacy data showing that study was unlikely to meet primary end point.

Results Point of Contact

• Title: Afshin Dowlati MD
• Organization: Case Comprehensive Cancer Center

afshin.dowlati@uhhospitals.org

216-844-1228

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 1, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 19, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-11

Locations

US (11)