Sunitinib and Capecitabine for First Line Colon Cancer

NCT00961571 | Terminated Phase 2 Results DMC

• 2 other identifiers: GA61822D2008-308
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancer; sunitinib; capecitabine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

sunitinib and cepecitabine

EXPERIMENTAL

Administration of sunitinib and capecitabine

Drug: sunitinib and capecitabine

Interventions

sunitinib and capecitabine DRUG

Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily

Also known as: Sunitinib, NSC 736511, Sutent, Capecitabine, Xeloda

sunitinib and cepecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• Pfizer: collaborator

Study Sites (1)

Lombardi Cancer Center at Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Sunitinib; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Aiwu Ruth He
• Organization: Georgetown University, Department of Medicine and Oncology

arh29@georgetown.edu

202-444-8642

Study Officials

• Aiwu Ruth He, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 12, 2025
• Results First Posted: April 21, 2017

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)