Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors
Given the lack of other viable treatment options for metastatic neuroendocrine tumors, contrasted with our positive anecdotal experience, and the relative tolerability of the treatment regimen for colorectal cancer patients, we propose a single-institution phase II trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Capecitabine, Oxaliplatin and Bevacizumab for Metastatic or Unresectable Neuroendocrine Tumors|
- 12-month Progression Free Survival (PFS) [ Time Frame: assessed every 3 months by RECIST ] [ Designated as safety issue: No ]PFS is defined as the time from enrollment until documented disease progression or death (whichever occurred first).
- Toxicity by CTCAE Version 3.0 [ Time Frame: Assessed at every visit (approx every 3 wks) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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).
- Overall Survival [ Time Frame: Continuous ] [ Designated as safety issue: No ]OS is defined as time from enrollment until death from any cause.
- Biochemical Markers [ Time Frame: Assessed every 3 weeks while on treatment ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Experimental: Bevacizumab (Avastin), Oxaliplatin (Eloxatin)||
850 mg/m2 by mouth twice a day for days 1-14 oa a 21 day cycleDrug: Oxaliplatin
130 mg/m2 intravenously on day 1 of a 21 day cycleDrug: Bevacizumab
7.5mg/kg Intravenous on day 1 of a 21 day cycle
- 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
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Pam Kunz||Stanford University|