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Investigator(s):
Tim F. Greten, M.D. Principal Investigator Phone: 301-451-4723 Fax: 301-480-8780 gretentf@mail.nih.gov	Austin G. Duffy, M.D. Co-Investigator Phone: 301-451-8340 Fax: 301-480-8780 duffya@mail.nih.gov
Referral Contact(s):
Suzanne Fioravanti, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-6544 Fax: 301-480-2590 fioravas@mail.nih.gov

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Key Eligibility Criteria:

• Phase I only: Diagnosis of advanced or metastatic carcinoma
• Patients must have disease that is not amenable to potentially curative resection or ablative techniques and have received at least one prior standard chemotherapeutic regimen for metastatic disease
• Phase II: Diagnosis of irinotecan-refractory* colorectal carcinoma (CRC)
• Has received prior treatment for advanced/metastatic disease with an oxaliplatin, bevacizumab, or EGFR inhibitor-containing (only for subjects with wild type Kras) regimen
• Disease that is amenable to biopsy and be willing to undergo tumor biopsy
• Measurable disease
• ECOG ≤ 2
• Adequate hematologic, hepatic, and renal function
• No uncontrolled intercurrent illness including hypertension (systolic BP > 160, diastolic BP > 100), ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Not pregnant or breast feeding

* Irinotecan-refractory will be defined as patients who have radiological evidence of disease progression while receiving irinotecan or within three months after completing it.

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Study Outline:

• Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study, including a test for the GPC-3 protein in the tumor cells
• Eligible participants will receive ISIS 183750 and irinotecan both administered by intravenous infusion (IV) (through a vein)
• ISIS 183750 is administered once a week (i.e., Days 1, 8, 15, and 22 of a 28-day cycle); in the first cycle, ISIS 183750 is also administered on Days 3 and 5
• Irinotecan is administered every second week, beginning on Day 15 of the first cycle
• Cycles will continue as long as the cancer does not grow and the side effects are not severe
• Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/12/12
Updated: 9/11/12