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Spots Global Cancer Trial Database for Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC

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Trial Identification

Brief Title: Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC

Official Title: Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III Non-Small Cell Lung Cancer

Study ID: NCT00960297

Study Description

Brief Summary: The rationale for this multicenter, phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.

Detailed Description: Adjuvant chemotherapy for patients with completely resected stage II and select stage III NSCLC is considered standard therapy. At least three large, prospective randomized trials have proven the benefit of adjuvant chemotherapy in improving survival in these patients (with a magnitude of benefit ranging from 4-12%). However, in patients who are not considered to be candidates for up-front complete resection, preoperative therapy may be indicated. Many of these patients will subsequently be eligible for resection (bimodality therapy). The rationale for this multicenter, Phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\>4.0 cm), II, and select stage III NSCLC. This trial will be conducted by the Sarah Cannon Research Institute Oncology Research Consortium. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Holy Cross Hospital, Fort Lauderdale, Florida, United States

Providence Medical Group, Terre Haute, Indiana, United States

Norton Cancer Institute, Louisville, Kentucky, United States

Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States

Portsmouth Regional Hospital, Portsmouth, New Hampshire, United States

Tennessee Oncology, Nashville, Tennessee, United States

Contact Details

Name: David R Spigel, M.D.

Affiliation: SCRI Development Innovations, LLC

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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