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Sunitinib and Capecitabine for First Line Colon Cancer

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: NCT00961571
Recruitment Status : Terminated (Unanticipated side effects and futility)
First Posted : August 19, 2009
Results First Posted : April 21, 2017
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ruth He, Georgetown University

Tracking Information
First Submitted Date  ICMJE August 18, 2009
First Posted Date  ICMJE August 19, 2009
Results First Submitted Date  ICMJE March 11, 2017
Results First Posted Date  ICMJE April 21, 2017
Last Update Posted Date April 3, 2018
Study Start Date  ICMJE August 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
Progression-free Survival [ Time Frame: 36 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
Progression-free survival [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
  • Toxicity [ Time Frame: 6 months ]
  • Overall survival [ Time Frame: 2 years ]
  • Objective Response [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunitinib and Capecitabine for First Line Colon Cancer
Official Title  ICMJE A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE Drug: sunitinib and capecitabine
Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
Other Names:
  • Sunitinib, NSC 736511, Sutent
  • Capecitabine, Xeloda
Study Arms  ICMJE Experimental: sunitinib and cepecitabine
Administration of sunitinib and capecitabine
Intervention: Drug: sunitinib and capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 18, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00961571
Other Study ID Numbers  ICMJE GA61822D
2008-308 ( Other Identifier: IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ruth He, Georgetown University
Original Responsible Party Aiwu Ruth He, MD, Georgetown University Medical Center
Current Study Sponsor  ICMJE Georgetown University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Aiwu Ruth He, MD Georgetown University
PRS Account Georgetown University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP