Sunitinib and Capecitabine for First Line Colon Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00961571
• Other study ID #: GA61822D
• Secondary ID: 2008-308
• Status: Terminated
• Phase: Phase 2
• First received: August 18, 2009
• Last updated: March 6, 2018
• Start date: August 2009
• Est. completion date: March 2011

Study information

• Verified date: December 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• sunitinib and capecitabine
Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily

Locations

Country	Name	City	State
United States	Lombardi Cancer Center at Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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