Sunitinib Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With ES-SCLC
Condition: Extensive-Stage Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: sunitinib
Intervention description: Sunitinib will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this study is to determine the progression-free survival rate in patients with
      extensive-stage small cell lung cancer who had achieved complete response, partial response,
      or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or
      carboplatin in combination with etoposide or irinotecan. In addition, the safety and
      effectiveness of sunitinib will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed extensive-stage SCLC. Extensive-stage is
             defined as disease that extends beyond one hemithorax and regional lymph nodes
             (ipsilateral or contralateral hilar, mediastinal, or supraclavicular lymph nodes), or
             with cytologically positive pleural effusion.

          -  Patients who have completed platinum-based chemotherapy and demonstrated a complete
             response, partial response, or stable disease can be registered on the trial. A
             maximum of 4 cycles of induction chemotherapy is allowed. Patients must begin therapy
             within 28-42 days after day 1 of the 4th cycle of induction therapy and within 28 days
             of scans demonstrating stable disease or better. Prior palliative radiation therapy
             will be allowed as long as radiation was completed at least 1 week before starting
             protocol therapy.

          -  Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or
             surgical procedures to NCI CTCAE Version 3.0 grade 1.

          -  Age * 18 years with Southwest Oncology Group (SWOG) performance status of 0,1 or 2
             (Appendix 2).

          -  Adequate organ function as evidenced by the laboratory values listed in the protocol

        Exclusion Criteria:

          -  Symptomatic or untreated brain or leptomeningeal metastases. Treated patients should
             be neurologically stable for at least 2 weeks after completion of appropriate therapy
             without the use of steroids. Patients currently on steroids are ineligible.

          -  More than 4 cycles of induction chemotherapy. Patients will be eligible for if they
             have completed at least 2 cycles of platinum-based induction chemotherapy and they
             have exhibited a complete or partial response to therapy. Patients who have received
             less than 4 cycles of induction chemotherapy and have less than a partial response
             will not be eligible.

          -  NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment.

          -  History of gross hemoptysis due to lung cancer.

          -  Previous or concurrent malignancies, with the exception of adequately treated squamous
             cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any
             other malignancy treated and in clinical remission for more than 3 years.

          -  Major surgery or within 4 weeks of starting study treatment.

          -  Any history of the following within the 6 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or
             transient ischemic attack, or pulmonary embolism.

          -  Ongoing cardiac dysrhythmias

          -  Hypertension that cannot be controlled by medications

          -  Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication.

          -  Therapeutic anticoagulation with warfarin or heparin.

          -  Serious concomitant medical illness, including, but not limited to, uncontrolled
             angina, myocardial infarction and/or stroke within 3 months, or HIV infection.

          -  Acute or chronic liver disease

          -  History of dementia, active psychiatric disorder or any other condition, considered by
             the treating physician to impair the patient's ability to take oral pills on a daily
             basis or comply with the protocol requirements.

          -  Pregnant or lactating females.

          -  Use of agents with proarrhythmic potential is not permitted during the study.