Metastatic Colorectal Cancer
Conditions
Keywords
colorectal cancer, sunitinib, capecitabine
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.
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.
Interventions
DRUGsunitinib and capecitabine
Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
Sponsors
Pfizer
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 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. |
Countries
United States
Participant flow
Recruitment details
From 2007 to 2008, we treated patients with unresectable advanced colorectal cancer with Sunitnib 37.5 mg orally once daily and Capecitabine 1000 mg orally twice daily in a phase II clinical trial at Georgetown University Hospital
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib and Cepecitabine Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 39 |
Baseline characteristics
| Characteristic | Sunitinib and Cepecitabine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 67 years |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 11 |
| other Total, other adverse events | 11 / 11 |
| serious Total, serious adverse events | 8 / 11 |
Outcome results
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.
Time frame: 36 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib and Cepecitabine | Progression-free Survival | 18.35 months |