Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer
Condition: Extensive Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: sorafenib tosylate
Intervention description: Given orally
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically-confirmed diagnosis of small cell
             lung cancer and must have extensive disease with progression or recurrence after
             receiving a standard first-time regimen containing either cisplatin or carboplatin;
             patients who receive primary curative chemoradiation therapy for limited disease, but
             who recur within the primary tumor site, previously radiated field or with distant
             metastases are also allowed to participate; diagnosis based on sputum cytology is
             acceptable if confirmation by an independent pathologic review at the institution is
             documented; patients who have clinical evidence of recurrent small cell lung cancer do
             not require a confirmatory biopsy to be eligible for this trial

          -  Patients must have measurable disease per RECIST criteria; patients must have evidence
             of disease by plain radiographs, CT scan or MRI scan; all x-rays/scans to assess
             measurable disease must have been performed within 28 days prior to registration; all
             other required test to assess non-measurable disease must be performed within 42 days
             prior to registration; all disease must be assessed

          -  Patients must have been previously treated with exactly one regimen; this must have
             included cisplatin or carboplatin; in addition, information must be available to place
             the patient in one of the two following categories:

               -  Platinum sensitive disease: defined as an initial response to platinum-based
                  chemotherapy who subsequently progressed > 90 days after last platinum treatment;
                  best response to platinum-based treatment: CR, PR, stable or progression while on
                  treatment (circle one); NOTE: Prior chemotherapy must have been completed at
                  least 90 days prior to registration OR

               -  Platinum refractory disease; no response to platinum-based chemotherapy,
                  progression during platinum-based therapy, or progression within 90 days of
                  completing platinum-based therapy

          -  Patient may have receive previous radiation therapy, but it must have been completed
             at least 21 days prior to registration and the patient should have recovered from all
             associated toxicities; there must be no plans for the patients to receive concurrent
             radiation therapy to measurable lesions; measurable disease may be present inside the
             area of prior radiation therapy provided that the lesion is demonstrated to be
             progressing by CT scan or there is measurable disease outside the prior radiation
             field

          -  Patients may have received prior surgery provided that at least 14 days have elapsed
             since surgery (thoracic or other major surgeries) and the patient has recovered from
             all associated toxicities; patients must have disease outside the area of previous
             surgical resection or a new lesion must be present

          -  CORRELATIVE SCIENCE STUDIES: Institutions must have IRB approval of S9925 (the Lung
             Cancer Specimen Repository); patients must be offered participation in S9925; with the
             patient's consent, specimens will be submitted for testing via S9925; patients must be
             registered separately to S9925 in order for institutions to receive credit for
             specimen submission

          -  Serum creatinine =< the institutional upper limit of normal OR creatinine clearance >=
             60 cc/min

          -  Bilirubin =< 2 x the institutional upper limit of normal

          -  Alkaline phosphatase =< 2 x the institutional upper limit of normal

          -  SGOT or SGPT =< 2 x the institutional upper limit of normal

          -  PTT and either PT or INR < 1.5 x the institutional upper limit of normal (except in
             patients who are on warfarin [Coumadin or heparin] obtained within 28 days prior to
             registration); patients who receive anti-coagulation treatment with an agent such as
             warfarin or heparin, prophylactically or therapeutically, will be allowed to
             participate

          -  Patients must not have any evidence of bleeding diathesis

          -  ANC >= 1,500/uL

          -  Platelet count >= 100,000/uL

          -  Patients must have a Zubrod performance status 0-1

          -  Patients with known brain and/or leptomeningeal metastases are eligible only if he/she
             is asymptomatic, without deficits on neurologic exam and is not receiving
             corticosteroid therapy to control symptoms; only a non-enzyme inducing anticonvulsant
             (e.g., Keppra) will be permitted for those patients requiring anticonvulsants; all
             patients must have a pretreatment CT or MRI scan of the brain to evaluate CNS disease
             within 28 days prior to registration

          -  Any ongoing requirement for systemic corticosteroid therapy is not permitted; topical
             and/or inhaled steroids are allowed

          -  Patients must either be able to swallow and/or receive enteral medications via
             gastrostomy feeding tube; patients with intractable nausea or vomiting are not
             eligible; patients with GI tract disease resulting in an inability to take oral
             medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical
             procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g.,
             Crohn's, ulcerative colitis) are not eligible

          -  The effects of BAY 43-9006 on the developing human fetus at the recommended
             therapeutic dose are unknown; for this reason, patients must not be pregnant or
             nursing; women/men of reproductive potential must have agreed to use an effective
             contraceptive method (hormonal or barrier method of birth control, abstinence) prior
             to study entry and for the duration of study participation; should a woman become
             pregnant or suspect she is pregnant while participating in this study, she should
             inform her treating physician immediately

          -  Patients must not have a significant history of cardiac disease, e.g., uncontrolled
             hypertension, unstable angina, congestive-heart failure, and myocardial infarction
             within the last six months, or cardiac ventricular arrhythmias requiring medication

          -  Patients must be willing to provide prior smoking history

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease-free for 5 years

          -  All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines

          -  At the time of patient registration, the treating institution's name and ID number
             must be provided to the Data Operations Center in Seattle in order to ensure that the
             current (within 365 days) date of institutional review board approval for this study
             has been entered into the data base