Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma
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|ClinicalTrials.gov Identifier: NCT02062749|
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : July 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Oxaliplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial With Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma|
|Actual Study Start Date :||May 19, 2014|
|Actual Primary Completion Date :||June 27, 2018|
|Actual Study Completion Date :||June 27, 2018|
Experimental: Hyperthermic Intraperitoneal Chemotherapy
After cytoreductive surgery and lysis of adhesions, two large bore catheters are placed in the peritoneal cavity through the incision. Thirty minutes before HIPEC is begun, body temperature is cooled to 35°C. ). The catheters are connected to a perfusion circuit. Heated Oxaliplatin is added to the perfusate administered over 90 minutes. The starting dose of Oxaliplatin is 175 mg/m2.
Starting dose of Oxaliplatin is 175 mg/m2 delivered by hyperthermic intraperitoneal chemotherapy over 90 minutes.
Other Name: Eloxatin
- Maximum Tolerate Dose (MTD) of Oxaliplatin in Hyperthermic Intraperitoneal Chemotherapy [ Time Frame: 3 months ]MTD is highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT). DLT may occur at any time during the initial hospitalization before discharge following the hyperthermic intraperitoneal chemotherapy (HITC). DLT defined in two ways: Hematologic DLT defined as Grade IV neutropenia, anemia, or thrombocytopenia; and Non-hematologic DLT is any Grade III or IV non-hematologic toxicity excluding Grade III nausea or vomiting, Grade III hepatic toxicity which returns to Grade I within two weeks of the HITC, or before hospital discharge, or Grade III fever occurring after the HITC.
- Differences in Genetic Aberrations in Pediatric Colon Cancer Patients and Adult Patients [ Time Frame: 6 months ]Descriptive statistics on genetic aberrations provided, either by tabulations of frequencies or summary statistics including numbers, mean, standard deviation, median, minimum and maximum, when appropriate.
- Time to Recurrence After HIPEC in Pediatric, Adolescent and Young Adult Age Colon Cancer Patients [ Time Frame: 6 months ]Time to recurrence defined as time from treatment to recurrence (event) or to last follow-up date (censored), using the Kaplan-Meier method, with 95% confidence interval. Evaluation of measurable disease by CT or MRI and physical exam.
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): NCT02062749
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Andrea Hayes-Jordan, MD||M.D. Anderson Cancer Center|