Sunitinib and Capecitabine for First Line Colon Cancer
This study has been terminated.
(Unanticipated side effects and futility)
Sponsor:
Georgetown University
Collaborator:
Pfizer
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00961571
First received: August 18, 2009
Last updated: March 23, 2011
Last verified: March 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic |
Drug: sunitinib and capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Georgetown University:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Objective Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | August 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961571
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
No publications provided
| Responsible Party: | Aiwu Ruth He, MD, Georgetown University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00961571 History of Changes |
| Other Study ID Numbers: | GA61822D, 2008-308 |
| Study First Received: | August 18, 2009 |
| Last Updated: | March 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Georgetown University:
|
colorectal cancer sunitinib capecitabine |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Neoplasms Neoplasms, Second Primary Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Capecitabine Fluorouracil |
Sunitinib Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013