Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of radioactive microsphere infusion as a treatment for liver metastases from colon or rectal cancer. The investigators hypothesis is that the administration of microspheres between first and second line chemotherapy will increase progression-free survival time by about 2.5 months and may also improve tumor response rates to subsequent second line chemotherapy.


Clinical Trial Description

This is a phase II, single-arm study of Yttrium-90 (Y-90) radioactive resin microspheres in the treatment of colorectal adenocarcinoma metastatic to the liver in patients who have had progressive disease through first line combination chemotherapy or have otherwise failed first line chemotherapy due to toxicity. Expected enrollment at University of California, San Diego (UCSD) is approximately 34 subjects. The dose of Yttrium-90 radioactive resin microspheres is calculated based on body surface area (to estimate normal liver volume), percentage of total liver represented by the targeted lobe, and percentage of the lobe that is occupied by tumor, corrected for percentage lung shunt. The prescribed dose, calculated by the nuclear medicine physician, will be delivered by the interventional radiologist using the standard delivery system with frequent fluoroscopic monitoring to assure ante grade blood flow immediately after treatment. Additional current standard practice includes obtaining a nuclear medicine scan of the patient immediately after each therapeutic Yttrium-90 microspheres administration to prove delivery of the agent to the targeted portion of the liver and absence of either extra-hepatic Yttrium-90 delivery or free Yttrium-90. Blood samples will be obtained one week after the first treatment with microspheres. If the patient has bi-lobar disease and the results of lab tests meet protocol specified criteria, the dose will be repeated in the initially-untreated lobe. If the lab tests do not meet protocol specified criteria (i.e. study inclusion/exclusion criteria), the treatment will be deferred for fourteen days and labs repeated. If they are then within parameters, the patient will receive the second dose. If they are not within parameters, the patient will proceed to chemotherapy. Patients will remain off chemotherapy after their final microspheres treatment for a minimum of three weeks. Second line treatment options include FDA approved anti-neoplastic agents used in colorectal cancer metastatic to the liver with the exception of bevacizumab and capecitabine, which has been less rigorously studied with relation to Yttrium-90 radioactive microspheres and therefore will not be used. When patients are found to have progressive disease while receiving second line chemotherapy, they will then undergo a comprehensive clinical, laboratory, and imaging assessment and enter the follow-up phase in which they are assessed every five to seven months until death or withdrawal of consent. A contrast enhanced ultrasound (CEUS) will be performed pre microsphere treatment (within 14 days), post microsphere treatment (2 weeks, 4 weeks, 8 weeks and 12 weeks post the microsphere treatment). If patients require two treatments with microspheres, they will be evaluated 2, 4, 8 and 12 weeks post the second treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01098422
Study type Interventional
Source University of California, San Diego
Contact
Status Terminated
Phase N/A
Start date January 2010
Completion date February 2015

See also
  Status Clinical Trial Phase
Recruiting NCT04552093 - Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT) Phase 2/Phase 3
Completed NCT04192565 - A Prospective Investigation of the ColubrisMX ELS System N/A
Completed NCT05178745 - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Recruiting NCT03561350 - Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Recruiting NCT06128798 - Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery. N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Completed NCT03631407 - Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046) Phase 2
Withdrawn NCT04192929 - Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02889679 - Underwater Resection of Non-pedunculated Colorectal Lesions N/A
Terminated NCT02842580 - De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT02564835 - Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer N/A
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Completed NCT02149108 - Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1) Phase 3
Completed NCT02599103 - The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects N/A
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Completed NCT01669109 - Hatha Yoga for Patients With Colorectal Cancer N/A
Recruiting NCT01428752 - Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer N/A
Completed NCT01978717 - General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer N/A
Completed NCT01877018 - Colorectal Cancer Screening in Primary Care N/A