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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00361244

Collaborator

Beth Israel Deaconess Medical Center (Other), Dana-Farber Cancer Institute (Other)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Carcinoma	Drug: SU011248 Drug: Irinotecan Drug: Cetuximab	Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Aug 1, 2010

Outcome Measures

Primary Outcome Measures

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 [1 year]
To determine the response rate of SU011248 when given in combination with irinotecan and cetuximab in this patient population. []

Secondary Outcome Measures

To evaluate the toxicities of this combination of drugs in this patient population [1 year]
to assess overall survival, progression-free survival, time to progression and duration of response. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115