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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Rectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Constantinos Sofocleous, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

09-030

NCT ID:

NCT00972036

Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • COLON
  • LIVER
  • RECTUM
  • SIR-Spheres
  • 09-030
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location

Memorial Sloan-Kettering Cancer Center 1275 York AvenueNew York, New York  10021