Sunitinib and Capecitabine for First Line Colon Cancer
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ClinicalTrials.gov Identifier: NCT00961571 |
Recruitment Status :
Terminated
(Unanticipated side effects and futility)
First Posted : August 19, 2009
Results First Posted : April 21, 2017
Last Update Posted : April 3, 2018
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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 |
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 (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 |

Arm | Intervention/treatment |
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Experimental: sunitinib and cepecitabine
Administration of sunitinib and capecitabine
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Drug: sunitinib and capecitabine
Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
Other Names:
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- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961571
United States, District of Columbia | |
Lombardi Cancer Center at Georgetown University | |
Washington, District of Columbia, United States, 20007 |
Principal Investigator: | Aiwu Ruth He, MD | Georgetown University |
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 Key Record Dates |
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 |
colorectal cancer sunitinib capecitabine |
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 |