Phase II Trial of Sunitinib (Sutent, SU11248) Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With Extensive-Stage Small Cell Lung Cancer

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.