CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01202409|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2010
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancer||Drug: Panitumumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Panitumumab in KRAS Wild-type Locally Advanced or Metastatic Adenocarcinoma of the Small Bowel or Ampulla of Vater|
|Actual Study Start Date :||November 2010|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2020|
Starting Dose of Panitumumab: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.
Starting Dose Level: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.
Other Name: Vectibix
- Response Rate (RR) of Patients [ Time Frame: After 4, 14 day cycles ]
The primary endpoint of this phase II, single arm study is response rate (RR) for patients treated with single-agent Panitumumab.
Patients evaluated for up to 8 cycles from their first dose, and a patient will be considered as a non-responder if no partial response (PR) or complete response (CR) has been documented after 8 cycles of treatment. Response and progression evaluated using new international RECIST criteria (version 1.1, 2009) proposed by RECIST committee. All patients who have measurable disease according to the RECIST criteria and who have their disease re-evaluated are evaluable for response.
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): NCT01202409
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Overman, MD||M.D. Anderson Cancer Center|