Sunitinib and Capecitabine for First Line Colon Cancer

• ClinicalTrials.gov Identifier: NCT00961571
• Recruitment Status: Terminated
• First Posted: August 19, 2009
• Results First Posted: April 21, 2017
• Last Update Posted: April 3, 2018
• Sponsor: Georgetown University
• Collaborator: Pfizer
• Information provided by (Responsible Party): Ruth He, Georgetown University

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Ruth He, Assistant Professor, Georgetown University
• ClinicalTrials.gov Identifier: NCT00961571
• Other Study ID Numbers: GA61822D; 2008-308 ( Other Identifier: IRB )
• First Posted: August 19, 2009
• Results First Posted: April 21, 2017
• Last Update Posted: April 3, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Ruth He, 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; Sunitinib; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors