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

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute
• Treatments: Camptothecin; Cetuximab; Irinotecan; Sunitinib

Criteria

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