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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer Metastatic

Thank you

Trial Information

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

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

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Aiwu Ruth He, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

March 2011

Related Keywords:

  • Colorectal Cancer Metastatic
  • colorectal cancer
  • sunitinib
  • capecitabine
  • Colorectal Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary



Lombardi Cancer Center at Georgetown UniversityWashington, District of Columbia  20007