Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT00398320|
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : December 10, 2013
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Capecitabine Drug: Oxaliplatin Drug: Bevacizumab||Phase 2|
- Determine an estimation of median time to progression (TTP) for patients treated with bevacizumab in combination with capecitabine and oxaliplatin
- Assess the toxicities associated with this regimen
- Determine objective response rate (RR) for patients treated with this regimen
- Conduct exploratory analyses of efficacy according to degree of tumor differentiation and primary location
- Determine utility of biochemical markers as a surrogate endpoint for tumor response
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Capecitabine, Oxaliplatin and Bevacizumab for Metastatic or Unresectable Neuroendocrine Tumors|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
|Experimental: Bevacizumab (Avastin), Oxaliplatin (Eloxatin)||
850 mg/m2 by mouth twice a day for days 1-14 oa a 21 day cycle
130 mg/m2 intravenously on day 1 of a 21 day cycle
7.5mg/kg Intravenous on day 1 of a 21 day cycle
- 12-month Progression Free Survival (PFS) [ Time Frame: PFS assessed every 3 months through 12 months ]Percentage of participants with 12-month progression-free survival (PFS) was assessed. PFS is defined as the time from enrollment until documented disease progression or death (whichever occurred first). RECIST criteria (version 1). Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR) defined as ≥ 30% decrease of SLD. Progressive disease (PD) defined as ≥ 20% increase in Sum Longest Diameters (SLD). Stable Disease (SD) defined as being between 20% increase and < 30% decrease in SLD.
- Number of Patients Who Experienced Treatment-related Grade 3 or Higher Adverse Events by CTCAE Version 3.0 [ Time Frame: 30 days after last treatment ]Participants were monitored every 3 weeks while on study. Toxicity and attributions were as per CTCAE version 3.0 guidelines. Analysis population below is patient who experienced related Grade 3 or higher AE; denominator is 40 total patients enrolled.
- Response Rates [ Time Frame: Response rates by RECIST criteria assessed every 3 months while on treatment ]Response rate is defined as percent of patients with complete response (CR) and partial response (PR) as their best response as defined by RECIST criteria (version 1). Complete response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as ≥ 30 decrease in the sum of longest diameters of target lesions (SLD). Overall response (OR) = CR + PR.
- Overall Survival (OS) [ Time Frame: Continuous ]OS is defined as time from enrollment until death from any cause.
- Biochemical Markers [ Time Frame: Assessed every 3 weeks while on treatment ]
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): NCT00398320
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Pamela L Kunz, MD||Stanford University|