A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Small Cell Lung Cancer

In brief

Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously tested and found to have significant single agent activity in relapsed SCLC, including in refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are associated with worse outcomes. Bevacizumab, a monoclonal antibody to VEGF, increase response rates and survival when combined with chemotherapy agents compared with the chemotherapy agent alone in NSCLC, breast cancer, and colorectal cancer. Paclitaxel plus bevacizumab, in the dose and schedule proposed in this study, improves response rates and progression free survival compared with paclitaxel alone in women with metastatic breast cancer. Therefore, we will be testing the safety, feasibility, and efficacy of this regimen in patients with chemosensitive relapsed SCLC.

Key facts

Study ID

NCT00317200

Run by

Hoosier Cancer Research Network

People needed

34

Starts

2006-04-01

Expected to finish

2007-11-01

Last updated by the study team

2011-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Highlands Oncology Group — Springdale, Arkansas, United States
• Medical & Surgical Specialists, LLC — Galesburg, Illinois, United States
• Cancer Care Center of Southern Indiana — Bloomington, Indiana, United States
• Oncology Hematology Associates of SW Indiana — Evansville, Indiana, United States
• Fort Wayne Oncology & Hematology, Inc — Fort Wayne, Indiana, United States
• Center for Cancer Care at Goshen Health System — Goshen, Indiana, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Quality Cancer Center (MCGOP) — Indianapolis, Indiana, United States
• Community Regional Cancer Center — Indianapolis, Indiana, United States
• Arnett Cancer Care — Lafayette, Indiana, United States
• Medical Consultants, P.C. — Muncie, Indiana, United States
• Center for Cancer Care, Inc., P.C. — New Albany, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Siteman Cancer Center — St Louis, Missouri, United States
• Methodist Cancer Center — Omaha, Nebraska, United States
• Pennsylvania Oncology-Hematology Associates — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center Extramural Research Program — Rockledge, Pennsylvania, United States

Full record on ClinicalTrials.gov

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