Status:
COMPLETED
A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Genentech, Inc.
Walther Cancer Institute
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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....
Detailed Description
OUTLINE: This is a multi-center study. Paclitaxel 90 mg/m2 IV infusion over 1 hour days 1, 8 and 15 of 28 day cycle Plus Bevacizumab 10 mg/kg on days 1 and 15 of 28 day cycle. * 1 cycle = 28 days ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00317200
Start Date
April 1 2006
End Date
November 1 2007
Last Update
May 2 2011
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Highlands Oncology Group
Springdale, Arkansas, United States, 72764
2
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
3
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
4
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714