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. 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 21, 2017
Information provided by (Responsible Party):
Ruth He, Georgetown University

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: sunitinib and capecitabine Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer
Study Start Date : August 2009
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: sunitinib and cepecitabine
Administration of sunitinib and capecitabine
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

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 24 months ]
    Progression-free survival (PFS) will be measured as the number of days between each patient's enrollment and his/her date of progression or date of death.

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 24 months ]
  2. Overall Survival [ Time Frame: 2 years ]
    Overall survival (OS) will be measured as the number of days between each patient's enrollment and his/her date of death.

  3. Objective Response [ Time Frame: 8 weeks ]
    complete response, partial response or stable disease per RECIST criteria.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00961571

United States, District of Columbia
Lombardi Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Principal Investigator: Aiwu Ruth He, MD Georgetown University

Responsible Party: Ruth He, Assistant Professor, Georgetown University Identifier: NCT00961571     History of Changes
Other Study ID Numbers: GA61822D
2008-308 ( Other Identifier: IRB )
First Posted: August 19, 2009    Key Record Dates
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: February 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ruth He, Georgetown University:
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors