MDACC Study Summary 2004-0779 (Archived)

Study Summary
No. 2004-0779:.......Colorectal......Ravi Murthy......Diagnostic Radiology

Study Summary Title



Study Summary Number:	2004-0779

Study Title:	Phase II Randomized study of SIR-Spheres, Yttrium microspheres with cetuximab plus irinotecan for patients with advanced colorectal cancer metastases to the liver

Physician

New Patient Referral



Name:	Ravi Murthy	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Diagnostic Radiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-0856 Contact us about clinical trials

General Information



Disease Group:	Colorectal	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every 4 weeks until off study and then at physician discretion as outlines in study calendar

Treatment Agents:	Cetuximab CPT-11 Yttrium 90	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	24 hours post therapy monitoring at the discretion of the treating physician

Description/
Intervention:

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.

Study Objectives / Outcomes

OBJECTIVES

Primary Objective:

Primary Objective: To determine the progression free survival for patients treated with the combination of liver directed therapy with SIR-Spheres followed by systemic chemotherapy with a combination of cetuximab with irinotecan for patients who have previously been treated.

Secondary Objectives:
1. To determine response rate, overall progression-free survival, and overall survival.
2. To evaluate toxicities and tolerability.

Study Status Information



Study Activation / Registration Date:	10/30/2009

IRB Review and Approval Date:	10/30/2009

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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. Adiagnostic 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 preceeding 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.

Links

Registration Number: NCT00766220
Study Information on Clinical Trials Registry (clinicaltrials.gov)