Sunitinib and Capecitabine for First Line Colon Cancer

This study has been terminated.
(Unanticipated side effects and futility)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ruth He, Georgetown University
ClinicalTrials.gov Identifier:
NCT00961571
First received: August 18, 2009
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Drug: sunitinib and capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Objective Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961571

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

No publications provided

Responsible Party: Ruth He, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT00961571     History of Changes
Other Study ID Numbers: GA61822D, 2008-308
Study First Received: August 18, 2009
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
colorectal cancer
sunitinib
capecitabine

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Sunitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014