90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT02512692|
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Intrahepatic Cholangiocarcinoma||Device: SIR-Spheres microspheres (Yttrium-90 Microspheres) Drug: Gemcitabine Drug: Cisplatin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2021|
Experimental: 90Y TARE with Gemcitabine and Cisplatin
90Y TARE will be given on day 3 or 4 of cycle 1 and start at 75% of the dose calculated by the body surface area formula and escalated by 25% per cohort in combination with cisplatin 25 mg/m2 and gemcitabine 300 mg/m2 in cycles 1 and 2.
Once the 90Y TARE has reached the 100% dose level, the gemcitabine dose will increase to 600mg/m2 in dose level 3 and 1000mg/m2 in dose level 4. The cisplatin dose will remain at 25/mg/m2.
For all dose levels, from cycle 3 to cycle 8, the cisplatin dose will be 25mg/m2 and the gemcitabine dose will be 1000mg/m2.
Device: SIR-Spheres microspheres (Yttrium-90 Microspheres)
On Day 3 or 4 of cycle 1 90Y TARE will be administered
Other Name: 90Y TARE
On days 1 and 8 of each cycle (21 days) Gemcitabine will be administered. Treatment may last up to 8 cycles
On days 1 and 8 of each cycle (21 days) Cisplatin will be administered. Treatment may last up to 8 cycles
- Presence or absence of a dose limiting toxicity (DLT) of 90Y TARE in combination with gemcitabine and cisplatin. [ Time Frame: 6 weeks of study treatment ]A continual reassessment method (CRM) design will be used to identify the maximum-tolerated dose (MTD)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512692
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Sarah Annand 843-792-9321 firstname.lastname@example.org|
|Principal Investigator:||Samuel L. Cooper, MD||Medical University of South Carolina|