Sunitinib and Capecitabine for First Line Colon Cancer

A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: sunitinib and capecitabine

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
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Lombardi Cancer Center at Georgetown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 months

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: Pfizer
• Investigators: Principal Investigator: Aiwu Ruth He, MD, Georgetown University

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: August 18, 2009
• First Submitted That Met QC Criteria: August 18, 2009
• First Posted (Estimate): August 19, 2009

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: colorectal cancer; sunitinib; capecitabine
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Capecitabine; Sunitinib
• Other Study ID Numbers: GA61822D; 2008-308 (Other Identifier: IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No