A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer
Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study
1 other identifier
interventional
34
1 country
17
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2006
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 20, 2006
CompletedFirst Posted
Study publicly available on registry
April 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedMay 2, 2011
April 1, 2011
1.6 years
April 20, 2006
April 28, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC).
18 months
Secondary Outcomes (4)
To determine the response rate of the combination of paclitaxel and bevacizumab with chemosensitive SCLC.
18 months
To determine the toxicity of the combination of paclitaxel and bevacizumab in patients with SCLC.
18 months
To determine overall survival.
18 months
To assess VEGF polymorphisms in the study population.
18 months
Study Arms (1)
1
ACTIVE COMPARATORPaclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.
Interventions
Eligibility Criteria
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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoosier Cancer Research Networklead
- Genentech, Inc.collaborator
- Walther Cancer Institutecollaborator
Study Sites (17)
Highlands Oncology Group
Springdale, Arkansas, 72764, United States
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401, United States
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202, United States
Community Regional Cancer Center
Indianapolis, Indiana, 46256, United States
Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Medical Consultants, P.C.
Muncie, Indiana, 47303, United States
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, 47150, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Siteman Cancer Center
St Louis, Missouri, 63110, United States
Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Pennsylvania Oncology-Hematology Associates
Philadelphia, Pennsylvania, 19106, United States
Fox Chase Cancer Center Extramural Research Program
Rockledge, Pennsylvania, 19046, United States
Related Publications (1)
Jalal S, Bedano P, Einhorn L, Bhatia S, Ansari R, Bechar N, Koneru K, Govindan R, Wu J, Yu M, Schneider B, Hanna N. Paclitaxel plus bevacizumab in patients with chemosensitive relapsed small cell lung cancer: a safety, feasibility, and efficacy study from the Hoosier Oncology Group. J Thorac Oncol. 2010 Dec;5(12):2008-11. doi: 10.1097/JTO.0b013e3181f77b6e.
PMID: 21102263RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nasser Hanna, M.D.
Hoosier Oncology Group, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 20, 2006
First Posted
April 24, 2006
Study Start
April 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
May 2, 2011
Record last verified: 2011-04