Clinical trial NCT00766220 (phase 2, status: withdrawn)
Conditions: colon cancer, colorectal cancer
ICD codes: C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: sir-spheres agent administration, cetuximab, irinotecan
SMILES: [90Y], [H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\C1=CSC(N)=N1)C(O)=O, CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O
Reason stopped: 
    slow accrual and withdrawn/exclusion of 2 participants.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed adenocarcinoma of the
             colon or rectum. Histology from the hepatic metastasis is not mandatory if the
             morphological appearances on cross sectional imaging and tumor markers (CEA) are
             indicative of a colorectal primary.

          2. Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in two dimensions (longest diameter to be recorded) as greater
             than or equal to 20 mm with conventional techniques or as greater than or equal to 10
             mm with spiral CT scan.

          3. Patients must have radiological evidence of disease progression of disease within 6
             months of their most recent dose of chemotherapeutic regimens .

          4. Age greater than or equal to 18 years.

          5. ECOG performance status less than or equal to 2.

          6. Patients must have normal organ and marrow function as defined below within 30 days of
             receiving the investigational agent: - leukocytes greater than or equal to 3,000/mL -
             absolute neutrophil count greater than or equal to 1,500/mL - platelets greater than
             or equal to 100,000/mL - total bilirubin less than or equal to 1.5 times upper limits
             of normal institutional limits - AST(SGOT) less than or equal to 3 X ULN and ALT(SGPT)
             less than or equal to 3 X ULN - Creatinine less than or equal to 1.5 times upper
             limits of normal institutional limits

          7. Patients with a prior history of non-colorectal cancer who have no active disease may
             be eligible if they are disease free for greater than or equal to 12 months prior to
             treatment.

          8. The effects of SIR-Spheres, irinotecan or cetuximab on the developing human fetus at
             the recommended therapeutic dose are unknown. For this reason and because radiation as
             well as other therapeutic agents used in this trial are known to be teratogenic, women
             of child-bearing potential and men must agree to use adequate contraception (hormonal
             or barrier method of birth control; abstinence) prior to study entry and for the
             duration of study participation. Should a woman become pregnant or suspect she is
             pregnant while in this study, she should inform her treating physician immediately.

          9. Ability to understand and the willingness to sign a written informed consent document.

         10. Patients without evidence of local disease recurrence from colorectal cancer are
             eligible

         11. Patients with extrahepatic disease confined to the lung is permitted if < 4 lesions
             are depicted on CTand all are < 3 cm in size

         12. Patients with brain mets are eligible for this trial if those patients who have had
             the area surgically resected or irradiated and have no evidence of active disease as
             demonstrated by MRI of the brain. Patients must have no evidence of residual
             neurological dysfunction as per baseline neurological exam. Patients with untreated
             brain metastases will be considered ineligible.

        Exclusion Criteria:

          1. Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or
             mitomycin C) prior to entering the study or those who have not recovered from adverse
             events due to agents administered more than 4 weeks earlier will be excluded. Patients
             who have had hepatic external beam radiotherapy will be excluded.

          2. Patients may not be receiving any other investigational agents.

          3. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to SIR-Spheres, irinotecan or cetuximab or other agents used in the study.

          4. Evidence of ascites, biopsy proven cirrhosis or portal hypertension suggested by the
             presence of characteristic imaging features on cross sectional imaging or esophageal
             varicosities demonstrated on endoscopy or barium swallow. A diagnostic study to rule
             out the presence of portal hypertension will not be required unless the findings on
             cross sectional imaging are suggestive but not confirmatory.

          5. Hepatic arterial anatomy that would prevent catheterization and the administration of
             SIR-Spheres into the liver.

          6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection requiring hospital admission or antibiotics,symptomatic congestive heart
             failure (class III and IV), unstable angina pectoris, cardiac arrhythmia, or
             psychiatric illness/social situations would exclude patients from this study.

          7. Contraindications to angiography and selective visceral catheterization: History of
             severe allergy or intolerance to any contrast media, or atropine. Bleeding diathesis,
             not correctable by usual forms of therapy that would include medical coagulopathy but
             not limited to the administration of blood products.

          8. Utilization of capecitabine for the 6 weeks preceding SIR-Sphere therapy and
             indefinitely following SIR-Sphere therapy as per manufacturer's recommendations due to
             the increased risk of radiation hepatitis.

          9. Patients exhibiting the mutant variety for kras will be excluded for participation in
             the study.