Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Mets to Liver

NCT00766220 | Withdrawn Phase 2 DMC

• 1 other identifier: 2004-0779
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical research study is to find out what effects radioactive particles, SIR-spheres, have when injected into the liver, followed by systemic chemotherapy with a combination of cetuximab and irinotecan compared to those who have systemic therapy alone, in patients with colon cancer that has metastasized to the liver. The safety of this treatment and how well it controls the disease will also be studied.

Conditions

Colon Cancer; Colorectal Cancer

Keywords

Colon; Liver; Colorectal cancer; Colorectal cancer metastases to the liver; Metastases to the liver; Colorectal cancer mets to liver; Colon cancer metastasized to liver; Yttrium microspheres; SIR-Spheres; Yttrium-90; Cetuximab; C225; Erbitux; IMC-C225; Irinotecan; CPT-11; Liver directed therapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  4 Months

Study Arms (2)

SIR-Spheres + Therapy

ACTIVE COMPARATOR

SIR-Spheres with Cetuximab + Irinotecan Therapy

Drug: SIR-spheres Agent Administration; Drug: Cetuximab; Drug: Irinotecan

Therapy Only

ACTIVE COMPARATOR

Cetuximab + Irinotecan Therapy

Drug: Cetuximab; Drug: Irinotecan

Interventions

SIR-spheres Agent Administration DRUG

SIR-Spheres, resin microspheres containing pure Beta emitter Yttrium-90, given through femoral catheter over 10 minutes.

Also known as: Yttrium-90, Yttrium 90, Yttrium microspheres

SIR-Spheres + Therapy

Cetuximab DRUG

400 mg/m2 by vein over 2 hours once a week. Cetuximab infusions will be continued weekly at a dose of 250 mg/m2 unless toxicity necessitates interruptions.

Also known as: C225, Erbitux™, IMC-C225

SIR-Spheres + Therapy; Therapy Only

Irinotecan DRUG

350 mg/m2 (or 300 mg/m2 in patients who are greater or equal to 70 years of age, or have an ECOG PS of 2 or have had prior pelvic and/or abdominal irradiation), by vein over 90 minutes, every three weeks.

Also known as: CPT-11

SIR-Spheres + Therapy; Therapy Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patients must have radiological evidence of disease progression of disease within 6 months of their most recent dose of chemotherapeutic regimens .
• Age greater than or equal to 18 years.
• ECOG performance status less than or equal to 2.
• 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
• 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.
• 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.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients without evidence of local disease recurrence from colorectal cancer are eligible
• Patients with extrahepatic disease confined to the lung is permitted if \< 4 lesions are depicted on CTand all are \< 3 cm in size
• 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.

You may not qualify if:

• 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.
• Patients may not be receiving any other investigational agents.
• 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.
• 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.
• Hepatic arterial anatomy that would prevent catheterization and the administration of SIR-Spheres into the liver.
• 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.
• 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.
• 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.
• Patients exhibiting the mutant variety for kras will be excluded for participation in the study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sirtex Medical: collaborator

Related Links

• MD Anderson Cancer Center website

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Interventions

Yttrium-90; Cetuximab; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Ravi Murthy, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: October 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 3, 2013

Record last verified: 2012-12