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Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

1-year

Safety Issue:

No

Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

CASE8507

NCT ID:

NCT00726986

Start Date:

July 2008

Completion Date:

July 2012

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Lake/University Ireland Cancer Center Mentor, Ohio  44060
MetroHealth Medical Center Cleveland, Ohio  44109
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
UH-Monarch Mayfield Heights, Ohio  44124
Southwest General Health Center Middleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical Center Orange Villager, Ohio  44122
UHHS Westlake Medical Center Westlaker, Ohio  44145
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195
UH-Firelands Sandusky, Ohio  44870
Columbia Presbyterian New York City, New York  10032
CCF-Fairview Hospital Cleveland, Ohio  44111