Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy

NCT00972036 | Completed Phase 1 DMC

• 1 other identifier: 09-030
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done with a new therapy called "Selective Internal Radiation Therapy" (known as SIRT). Radiation is an effective treatment for destroying tumors. It is widely used in cancer treatment. However, radiation can harm normal tissue. SIR-Spheres are tiny plastic beads. They contain a radioactive agent called Yttrium-90. These beads can be delivered through a small tube inserted into the blood vessel that goes directly to the tumor. The radiation goes directly to the tumor. This spares healthy parts of your liver.

Conditions

Colon Cancer; Rectal Cancer

Keywords

COLON; LIVER; RECTUM; SIR-Spheres; 09-030

Outcome Measures

Primary Outcomes (1)

• To determine the safety, toxicity, and maximum tolerated dose of SIR-Spheres® in patients with unresectable metastatic colorectal cancer to the liver (CLM) who have received previous hepatic arterial infusion chemotherapy (HAC).

  2 years

Secondary Outcomes (1)

• To obtain preliminary evidence of any clinical efficacy of the SIRT therapy in these heavily pretreated patients with unresectable CLM who have received hepatic arterial infusion pump and have failed at least one line of prior chemotherapy.

  2 years

Study Arms (1)

Unresectable colon cancer patients with liver metastases

EXPERIMENTAL

This study will be performed to evaluate the safety of Selective Internal Radiation Therapy (SIRT) in patients with liver only colorectal cancer metastases that have received hepatic arterial infusion pump and have progressed through at least one line of chemotherapy.

Device: SIR-spheres® (Selective Internal Radiation Therapy)

Interventions

SIR-spheres® (Selective Internal Radiation Therapy) DEVICE

SIR-spheres® will be administered at 70%, 85% and 100% of the calculated individual patient dose (approximately 1 month prior to SIR-spheres® administration).The first cohort will receive SIRSpheres® at 70% of the individually calculated patient dose, the second will receive 85% of the calculated patient dose, and the third will receive 100% of the calculated patient dose.

Unresectable colon cancer patients with liver metastases

Eligibility Criteria

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

You may qualify if:

• Histologic confirmation of colorectal cancer.
• Unequivocal imaging of hepatic metastases.
• Dominant Liver metastases. (Small amount extrahepatic disease allowed.)
• Unresectable liver metastases.
• Liver Metastases non-eligible for, or progressed after ablation
• Failed prior HAC.
• ECOG performance status 0 - 1
• WBC \> or = to 1.5 x 109/L
• Platelets \> or = to 50 x 109/L
• Creatinine ≤ 1.5 mg/dl
• Bilirubin ≤ 1.5 mg/dl
• Age \> or = to 18 years
• Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active, must agree to use an acceptable method of contraception.
• Male patients must be surgically sterile, or if sexually active, must agree to use an acceptable method of contraception.
• Life expectancy of at least 3 months without any active treatment.

You may not qualify if:

• Evidence of severe cirrhosis (CHILDS B and C), portal hypertension with gastroesophageal varices and liver failure as determined by clinical, radiologic or laboratory assessment.
• Previous radiotherapy delivered to the liver.
• Pregnant or breast-feeding.
• With a Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy that shows any disposition to the gastrointestinal tract that cannot be corrected by angiographic and embolization techniques.
• With more than 20% shunting of blood to the lungs as estimated in the Lung Scintigram performed after the intraarterial injection of Tc MAA. Radiation pneumonitis has been seen in patients receiving doses of Yttrium-90 greater than 30 Gy in a single treatment. This corresponds to the shunt over 20% presence of vascular abnormalities, bleeding diathesis, making catheterization of the hepatic artery contraindication.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Sirtex Medical: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center 1275 York Avenue

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Constantinos Sofocleous, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (1)