SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer



Status:Terminated
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/18/2017
Start Date:July 2006
End Date:August 2010

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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

The purpose of this study is to determine the safety of SU011248 and the highest dose of
this drug that can be given safely in combination with the chemotherapy drugs irinotecan and
cetuximab. Laboratory studies have shown that SU011248 may block the growth of blood vessels
in tumors, which may prevent tumors from growing any further. Other studies have
demonstrated the possibility that SU011248 may enhance the anti-tumor activity of other
chemotherapy drugs such as irinotecan and cetuximab.

- 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
period.

- 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 cetuximab.

- 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
Avastin.

- > 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
We found this trial at
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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