Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study

Inclusion Criteria:

- Histologic or cytologic proof of small cell lung cancer

- Chemo-sensitive disease defined as relapsed after 60 days from completion of first
line chemotherapy.

- Measurable disease according to RECIST and obtained by imaging within 28 days prior
to being registered for protocol therapy.

- Must have received treatment with at least 1 but not more than 2 prior chemotherapy
regimens. (At least one regimen must contain a platinum agent. Previous treatment
with irinotecan is allowed.)

- Prior radiation therapy must be completed at least 21 days prior to being registered
for protocol therapy, and toxicities due to radiation must have recovered to ≤ grade
1 or baseline prior to registration.

- Prior cancer treatment must be completed at least 21 days prior to being registered
for protocol therapy and the subject must have recovered from the acute toxicity
effects of the regimen prior to registration.

Exclusion Criteria:

- No treatment with any investigational agent within 30 days prior to being registered
for protocol therapy.

- No history or radiographic evidence of CNS involvement by head CT or MRI within 42
days prior to registration.

- No history of seizures, transient ischemic attack or stroke.

- No clinically significant infections as judged by the treating investigator.

- No other active cancer except SCLC.

- No prior treatment with topoisomerase I inhibitor.

- No contraindications to the use of paclitaxel or bevacizumab as per the
investigator's clinical judgment.

- Must not have grade 3 or greater peripheral neuropathy.

- Must not have had major surgical procedure, open biopsy, or significant traumatic
injury within 28 days of being registered for protocol therapy.

- No anticipation of need for major surgical procedure during the course of the study.

- Patients may not have had a minor surgical procedure, placement of an access device
or fine needle aspiration within 7 days prior to being registered for protocol
therapy.

- No evidence of bleeding diathesis or coagulopathy.

- No history of deep vein thrombosis or pulmonary embolism.

- No full dose/therapeutic anticoagulation with either low molecular weight heparin or
unfractionated heparin or coumadin within 10 days prior to registration.

- Patients must not have been using aspirin (>325 mg/day) or another nonsteroidal
anti-inflammatory medications known to inhibit platelet function on a daily basis
within 10 days prior to registration on study.

- Patients must not be using any of the following drugs known to inhibit platelet
function within 10 days prior to registration: dipyridamole (Persantine), ticlopidine
(Ticlid), clopidogrel (Plavix) and cilostazol (Pletal).

- Patients must not have a current non-healing wound or fracture.

- Patients must not have a history of or current hemoptysis.