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A Phase I/II Study of SU011248 (Sutent) in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Patients With Stage IV Colorectal Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Colorectal Carcinoma

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Trial Information

A Phase I/II Study of SU011248 (Sutent) in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Patients With Stage IV Colorectal Cancer

- Participants will be given a supply of SU011248 capsules to take at home in the morning
for two weeks. After taking the capsules for two weeks, there will be a one-week rest

- Irinotecan will be administered on days 1 and 8 of every 21-day cycle as an intravenous
infusion over 90 minutes. Cetuximab will be administered intravenously on days 1, 8
and 15 of every 21-day cycle. The first treatment of cetuximab is a larger dose.
Beginning with the second treatment, the participant will receive a smaller dose of

- Blood work will be repeated at every clinic visit on days 1 and 8. During cycle 1,
blood will also be drawn on day 15.

- Tumor assessments will be repeated after 6 weeks, 12 weeks, and every 9 weeks
thereafter, and will be assessed by both a CT scan of the abdomen, pelvis, and a chest
x-ray. MUGA scans will be repeated every 4 cycles (12 weeks).

- Participants may continue to receive cycles of study treatment as long as their disease
does not progress and they do not experience any serious side effects.

Inclusion Criteria:

- Histologic proof of adenocarcinoma of the colon or rectum with evidence of metastatic
disease. The site of the primary lesion must be or have been confirmed
endoscopically, radiologically, or surgically to be or have been in the large bowel

- Patients must have received one (and only one) prior chemotherapy regimen for
metastatic disease using 5-FU/LV or Xeloda in combination with oxaliplatin and

- > 4 weeks must have elapsed from the time of major surgery

- > 2 weeks must have elapsed from the time of minor surgery

- > 4 weeks must have elapsed from the time of major radiotherapy

- Normal organ and marrow function

- Measurable disease be RECIST criteria

- Older than 18 years of age

- ECOG performance status of 0-1

- Life expectancy > 12 weeks

Exclusion Criteria:

- Previous treatment with irinotecan, cetuximab or SU011248

- Any of the following within the 12 months prior to study drug administration:
severe/unstable angina; myocardial infarction; symptomatic congestive heart failure;
cerebrovascular accident; or transient ischemic attack.

- Known brain metastases or carcinomatous meningitis

- Uncontrolled serious medical or psychiatric illness

- NCI CTCAE grade 3 or greater hemorrhage within 4 weeks of starting study treatment

- Uncontrolled hypertension

- Diagnosis of any secondary malignancies with the last 5 years, except for adequately
treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer
with a normal PSA within the past 3 months, in situ bladder cancer, or in situ
cervical cancer

- Pregnant or breastfeeding

- Concurrent treatment on another clinical trial

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose of SU011248 when given in combination with irinotecan and cetuximab in patients with previously treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Andrew X. Zhu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

Related Keywords:

  • Colorectal Carcinoma
  • Sutent
  • Carcinoma
  • Colorectal Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617