S0435: Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00182689
First received: September 15, 2005
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

RATIONALE: Sorafenib may stop the growth of small cell lung cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: sorafenib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST) [ Time Frame: 8 weeks to 2 years ] [ Designated as safety issue: No ]
    Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.


Secondary Outcome Measures:
  • Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [ Time Frame: Patients were assessed for adverse events after completion of every 28-day cycle. ] [ Designated as safety issue: Yes ]
    Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

  • Overall Survival [ Time Frame: 0 - 2 years ] [ Designated as safety issue: No ]
    Measured from time of registration to death, or last contact date


Enrollment: 89
Study Start Date: July 2005
Study Completion Date: July 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib
Oral sorafenib 400 mg twice daily for 28 day cycle.
Drug: sorafenib
400 mg BID (two 200 mg tablets BID, total daily dose is 800 mg) Oral on Days 1-28. Continuous daily dosing.
Other Name: Bay 54-9085

Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of sorafenib, in terms of response rate (confirmed and unconfirmed, complete and partial), in patients with platinum-refractory or platinum-sensitive small cell lung cancer.

Secondary

  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine the overall survival of patients treated with this drug.
  • To collect specimens via the Lung Cancer Specimen Repository Protocol (S9925) in order to perform exploratory analyses of the relationship between selected markers and patient outcomes. [Analysis is ongoing and will be reported separately.]

OUTLINE: This is a multicenter study. Patients are stratified according to platinum sensitivity status (platinum sensitive vs platinum refractory).

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 2 years from study entry.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per stratum) will be accrued for this study within approximately 7-13 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer

    • Extensive stage with disease progression or recurrence after first-line therapy with either a cisplatin or carboplatin
    • Patients who received prior primary curative chemoradiotherapy for limited stage disease but who have experience subsequent recurrent disease* within the primary tumor site or previously irradiated field OR with distant metastases are eligible NOTE: *Patients with clinical evidence of recurrent disease do not require a confirmatory biopsy to be eligible
  • Measurable disease by plain radiographs, CT scan, or MRI within the past 28 days

    • Measurable disease inside the prior radiotherapy field allowed provided the lesion is progressing by CT scan OR there is measurable disease outside of the prior radiotherapy field
    • Must have disease outside the area of prior surgical resection OR a new lesion must be present
  • Must have received only 1 prior platinum-based regimen which contained either a cisplatin or carboplatin AND have the information necessary to be placed in 1 of the following groups:

    • Platinum-sensitive disease, defined as an initial response to platinum-based therapy and subsequent progression > 90 days after last platinum-based treatment
    • Platinum-refractory disease, defined as no response to platinum-based therapy, disease progression during platinum-based therapy, or disease progression ≤ 90 days after completion of platinum-based therapy
  • Brain or leptomeningeal metastases by CT scan or MRI allowed provided the patient is asymptomatic, has no deficits on neurologic exam, and is not receiving corticosteroid therapy to control symptoms

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • ALT or AST ≤ 2 times ULN
  • PT OR INR AND PTT < 1.5 times ULN (except for patients on warfarin or heparin)

Renal

  • Creatinine normal OR Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No significant history of cardiac disease, including any of the following:

    • Uncontrolled hypertension
    • Unstable angina
    • Congestive heart failure
    • Myocardial infarction within the past 6 months
    • Cardiac ventricular arrhythmias requiring medication

Gastrointestinal

  • No uncontrolled inflammatory gastrointestinal (GI) disease (e.g., Crohn's disease or ulcerative colitis)
  • No intractable nausea or vomiting
  • No GI tract disease resulting in an inability to take oral medication
  • No malabsorption syndrome
  • No requirement for IV alimentation
  • Able to swallow pills and/or receive enteral medications via gastrostomy feeding tube

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Willing to provide smoking history
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • At least 90 days since prior chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent systemic corticosteroids

    • Concurrent topical and/or inhaled steroids allowed

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy to measurable lesions

Surgery

  • See Disease Characteristics
  • At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered
  • No prior surgical procedures affecting absorption

Other

  • Concurrent prophylactic or therapeutic anticoagulation treatment with warfarin or heparin allowed
  • Concurrent nonenzyme-inducing anticonvulsants (e.g., Keppra^®) allowed for patients requiring anticonvulsants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182689

Sponsors and Collaborators
Investigators
Study Chair: Barbara J. Gitlitz, MD University of Southern California
Principal Investigator: Bonnie S. Glisson, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Gitlitz BJ, Glisson BS, Moon J, et al.: Sorafenib in patients with platinum (plat) treated extensive stage small cell lung cancer (E-SCLC): A SWOG (S0435) phase II trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-8039, 2008.

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00182689     History of Changes
Other Study ID Numbers: NCI-2012-03074, U10CA032102, S0435, CDR0000440068
Study First Received: September 15, 2005
Results First Received: August 20, 2012
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer
recurrent 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
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014