Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT01208103|
Recruitment Status : Completed
First Posted : September 23, 2010
Results First Posted : January 18, 2020
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ampulla of Vater Adenocarcinoma Small Intestinal Adenocarcinoma Stage III Ampulla of Vater Cancer AJCC v8 Stage III Small Intestinal Adenocarcinoma AJCC v8 Stage IIIA Ampulla of Vater Cancer AJCC v8 Stage IIIA Small Intestinal Adenocarcinoma AJCC v8 Stage IIIB Ampulla of Vater Cancer AJCC v8 Stage IIIB Small Intestinal Adenocarcinoma AJCC v8 Stage IV Ampulla of Vater Cancer AJCC v8 Stage IV Small Intestinal Adenocarcinoma AJCC v8||Biological: Bevacizumab Drug: Capecitabine Drug: Oxaliplatin||Phase 2|
I. To determine the progression-free survival (PFS) at six months for patients with advanced adenocarcinoma of the small bowel (small intestine) or ampulla of Vater treated with capecitabine, oxaliplatin (CAPOX) and bevacizumab.
I. To determine the response rate (RR) for CAPOX and bevacizumab. II. To determine the overall progression free survival for CAPOX and bevacizumab.
III. To determine the overall survival (OS) for CAPOX and bevacizumab. IV. To determine the toxicity of CAPOX and bevacizumab.
Participants receive oxaliplatin via central venous catheter (CVC) over 2 hours and bevacizumab intravenously (IV) over 30-90 minutes on day 1. Participants also receive capecitabine orally (PO) twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 10 and 30 days, and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bevacizumab Combined With Capecitabine and Oxaliplatin (CAPOX) in Patients With Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater|
|Actual Study Start Date :||May 6, 2011|
|Actual Primary Completion Date :||March 7, 2018|
|Actual Study Completion Date :||March 7, 2018|
Experimental: Treatment (oxaliplatin, bevacizumab, capecitabine)
Participants receive oxaliplatin via CVC over 2 hours and bevacizumab IV over 30-90 minutes on day 1. Participants also receive capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Number of Participants With Progression-free Survival (PFS) at Six Months [ Time Frame: 6 months ]A Bayesian sequential monitoring design will be used. PFS will be estimated using the Kaplan-Meier method.The length of time interval in months from date of first treatment, during and after the treatment a participant lives without progression.
- To Determine the Response Rate (RR) for CAPOX and Bevacizumab [ Time Frame: 39 months ]Complete response + Partial response using RECIST 1.1 (Response Evaluation Criteria in Solid Tumor)
- To Determine the Overall PFS for CAPOX and Bevacizumab [ Time Frame: 39 months ]Time interval in months from date of first treatment until the date of first documented progression
- To Determine the Overall Survival (OS) for CAPOX and Bevacizumab [ Time Frame: 39 months ]The length of time interval in months from date of first treatment until the date of death or lost follow-up
- Number of Participants With Adverse Events [ Time Frame: 39 months ]Toxicity was graded according to the NCI Common terminology Criteria for Adverse Events (CTCAE) 4.0 except for neurosensory and skin toxicity. Neurosensory toxicity was graded according to the Neurologic Toxicity Scale for Oxaliplatin Dose Adjustments.
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): NCT01208103
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Overman||M.D. Anderson Cancer Center|