A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00317200|
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : May 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Paclitaxel Drug: Bevacizumab||Phase 2|
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
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
- 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
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN
- Urine protein:creatinine ratio <1.0
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
Active Comparator: 1
Paclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.
Paclitaxel 90 mg/m2 IV infusion over 1 hour, days 1, 8 and 15 of 28 day cycle.
Bevacizumab 10 mg/kg, days 1 and 15 of 28 day cycle
- To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC). [ Time Frame: 18 months ]
- To determine the response rate of the combination of paclitaxel and bevacizumab with chemosensitive SCLC. [ Time Frame: 18 months ]
- To determine the toxicity of the combination of paclitaxel and bevacizumab in patients with SCLC. [ Time Frame: 18 months ]
- To determine overall survival. [ Time Frame: 18 months ]
- To assess VEGF polymorphisms in the study population. [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317200
|Study Chair:||Nasser Hanna, M.D.||Hoosier Oncology Group, LLC|