Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Sirtex Medical
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00972036
First received: September 3, 2009
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer Rectal Cancer |
Device: SIR-spheres® (Selective Internal Radiation Therapy) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Unresectable colon cancer patients with liver metastases
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)
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- No chemotherapy regimen administration for at least 4 weeks prior to SIRT administration
Exclusion Criteria:
- 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.
Any of the following are contraindications to the use of Yttrium-90 microspheres, and are therefore exclusion criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972036
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center 1275 York Avenue | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Sirtex Medical
Investigators
| Principal Investigator: | Constantinos Sofocleous, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00972036 History of Changes |
| Other Study ID Numbers: | 09-030 |
| Study First Received: | September 3, 2009 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
COLON LIVER RECTUM SIR-Spheres 09-030 |
Additional relevant MeSH terms:
|
Colonic Neoplasms Rectal Neoplasms Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013