NCT00317200

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 (4 weeks) * Disease assessments will be performed per RECIST every other cycle * After a minimum of 4 cycles or a maximum of 6 cycles of combination chemotherapy, bevacizumab monotherapy may continue until disease progression or intolerable side effects ECOG Performance Status 0 or 1 Hematopoietic: * White blood cell count \> 3,000 mm3 * Absolute neutrophil count (ANC) \> 1,500 mm3 * Platelet count \> 100,000 mm3 * International normalized ration (INR) of prothrombin time ≤ 1.2 * PTT no more than 5 seconds longer than the ULN Hepatic: * Bilirubin \< 1.5 x ULN * Aspartate aminotransferase (AST, SGOT) \< 2.5 x ULN Renal: * Urine protein:creatinine ratio \<1.0 Cardiovascular: * No history of myocardial infarction or angina pectoris/anginal equivalent in the last 6 months. Note: The patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months. * No history of uncontrolled congestive heart failure or uncontrolled hypertension

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel 90 mg/m2 IV infusion over 1 hour, days 1, 8 and 15 of 28 day cycle.
DRUG	Bevacizumab	Bevacizumab 10 mg/kg, days 1 and 15 of 28 day cycle

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-04-24
• Last updated: 2011-05-02

Locations

17 sites across 1 country: United States