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A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer



- 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.


- Determine the qualitative and quantitative toxic effects of this drug in these

- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- No bleeding diathesis


- 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)


- Creatinine normal OR Creatinine clearance ≥ 60 mL/min


- 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


- 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


- 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


Biologic therapy

- Not specified


- 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


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy to measurable lesions


- See Disease Characteristics

- At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered

- No prior surgical procedures affecting absorption


- Concurrent prophylactic or therapeutic anticoagulation treatment with warfarin or
heparin allowed

- Concurrent nonenzyme-inducing anticonvulsants (e.g., Keppra^®) allowed for patients
requiring anticonvulsants

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)

Outcome Description:

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.

Outcome Time Frame:

8 weeks to 2 years

Safety Issue:


Principal Investigator

Barbara J. Gitlitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

July 2011

Related Keywords:

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