Back to resultsSunitinib and Capecitabine for First Line Colon Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sunitinib and capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring colorectal cancer, sunitinib, capecitabine
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed, newly diagnosed metastatic colorectal cancer
- Measurable or evaluable disease in which surgical resection with curative intent is not possible
- No adjuvant chemotherapy within 6 months of enrollment
- No prior sunitinib or other receptor tyrosine kinase inhibitors
- 18 years of age or greater
- Anticipated survival of at least 6 months
- Ambulatory with an ECOG performance status of 0 or 1 and able to maintain weight
- Normal organ and marrow function
- Must agree to avoid pregnancy or fathering a child through out study participation
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
- Chemotherapy or radiotherapy within 6 months of enrollment
- Receiving any other investigational agents
- Known untreated brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis
- Not able to ingest oral medications with normal absorption from the GI tract
- Uncontrolled hypertension
- History of severe/unstable angina, heart attack, congestive heart failure, transient ischemic attack, or stroke within 6 months of enrollment
- Cardiac dysrhythmias
- History of clinically significant bleeding within the past 6 months, including gross hemoptysis or hematuria, or underlying coagulopathy
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study enrollment
- Current treatment with therapeutic doses of coumadin
- Concurrent malignancy other than colorectal cancer
- Known dihydropyrimidine dehydrogenase deficiency
- Uncontrolled intercurrent illness including ongoing or active infection or psychiatric illness that would limit compliance with study requirements.
- Pregnant and nursing women
Sites / Locations
- Lombardi Cancer Center at Georgetown University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sunitinib and cepecitabine
Arm Description
Administration of sunitinib and capecitabine
Outcomes
Primary Outcome Measures
Progression-free Survival
Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.
Secondary Outcome Measures
Full Information
NCT ID
NCT00961571
First Posted
August 18, 2009
Last Updated
March 6, 2018
Sponsor
Georgetown University
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00961571
Brief Title
Sunitinib and Capecitabine for First Line Colon Cancer
Official Title
A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Unanticipated side effects and futility
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and Sunitinib can be used together to improve progression-free survival in colorectal cancer.
All patients will take two medicines (Sunitinib and Capecitabine) by mouth every day until their cancer gets worse.
Detailed Description
This is a single-center, open-label, one-arm study. Patients will be stratified by prior adjuvant therapy and ECOG performance status at study entry.
In this study, we propose to obtain PET scans at baseline, 2 weeks, 8 weeks and 24 weeks from the initiation of treatment. Response at 2 weeks, 8 weeks and 24 weeks will be correlated to progression-free survival, overall survival and response according to RECIST criteria.
We will collect plasma and urine samples from enrolled patients before and four weeks after sunitinib treatment. The samples will be analyzed and results correlated with patient clinical outcomes in order to explore the underlying mechanism of sunitinib induced hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
colorectal cancer, sunitinib, capecitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sunitinib and cepecitabine
Arm Type
Experimental
Arm Description
Administration of sunitinib and capecitabine
Intervention Type
Drug
Intervention Name(s)
sunitinib and capecitabine
Other Intervention Name(s)
Sunitinib, NSC 736511, Sutent, Capecitabine, Xeloda
Intervention Description
Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed, newly diagnosed metastatic colorectal cancer
Measurable or evaluable disease in which surgical resection with curative intent is not possible
No adjuvant chemotherapy within 6 months of enrollment
No prior sunitinib or other receptor tyrosine kinase inhibitors
18 years of age or greater
Anticipated survival of at least 6 months
Ambulatory with an ECOG performance status of 0 or 1 and able to maintain weight
Normal organ and marrow function
Must agree to avoid pregnancy or fathering a child through out study participation
Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
Chemotherapy or radiotherapy within 6 months of enrollment
Receiving any other investigational agents
Known untreated brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis
Not able to ingest oral medications with normal absorption from the GI tract
Uncontrolled hypertension
History of severe/unstable angina, heart attack, congestive heart failure, transient ischemic attack, or stroke within 6 months of enrollment
Cardiac dysrhythmias
History of clinically significant bleeding within the past 6 months, including gross hemoptysis or hematuria, or underlying coagulopathy
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study enrollment
Current treatment with therapeutic doses of coumadin
Concurrent malignancy other than colorectal cancer
Known dihydropyrimidine dehydrogenase deficiency
Uncontrolled intercurrent illness including ongoing or active infection or psychiatric illness that would limit compliance with study requirements.
Pregnant and nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiwu Ruth He, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lombardi Cancer Center at Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sunitinib and Capecitabine for First Line Colon Cancer
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