Metastatic Colorectal Cancer
Conditions
Keywords
5-fluorouracil (5-FU), pharmacokinetic assay
Brief summary
The purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer.
Detailed description
5-fluorouracil (5-FU) has been the most widely used agent in the treatment of early stage and advanced colorectal cancer. Traditionally, 5-FU dosing is based on body surface area (BSA). However, BSA-dosing has been associated with a wide range of pharmacokinetic (PK) variability, resulting in marked differences in drug exposure and toxicities in an individual. There is a significant association between the risk of 5-FU-related toxicities and the extent of 5- FU systemic exposure, which can be measured using a well-established pharmacokinetic (PK) assay.
Interventions
DRUGBiweekly 5-FLUOROURACIL (5-FU)
5-FU 2400 mg/m². Infusion for 46 hours. Leucovorin 200 mg/m². Either a vascular endothelial growth factor (VEGF) inhibitor or epidermal growth factor (EGFR) inhibitor or may be added to the regimen at the discretion of the treating physician. Repeat every 2 weeks.
DRUGBiweekly Modified FOLFOX6
Oxaliplatin 85 mg/m². 5-FU 400 mg/m² on day 1 as bolus (OPTIONAL). 5-FU 2400 mg/m² Infusion for 46 hours. Leucovorin 200 mg/m2. Repeat every 2 weeks
DRUGBiweekly FOLFIRI
Irinotecan 180 mg/m2. 5-FU 400 mg/m2 on day 1 as bolus (OPTIONAL). 5-FU 2400 mg/m2 Infusion for 46 hours. Leucovorin 200 mg/m2. Repeat every 2 weeks.
DRUGmFOLFOXIRI
Irinotecan 165 mg/m2. Oxaliplatin 85 mg/m2. 5-FU 2400 mg/m2 Infusion for 46 hours. Repeat every 2 weeks.
Sponsors
Inova Health Care Services
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each cycle of chemotherapy is 2 weeks long, so you will be receiving treatment on the study for a total of 8 weeks. You will also need additional imaging (CT scans) after you complete the first four cycles of chemotherapy, which brings your total time in the study to about 3 months including treatment and follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females at least 18 years of age. * Histologically confirmed metastatic colorectal cancer eligible for treatment with 5-FU. * No prior therapy for metastatic disease. If adjuvant 5-FU or FOLFOX was administered, the last dose must have been at least 6 months prior to the diagnosis of metastatic disease. * Adequate organ function. * Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2. * Life expectancy \> 3 months.
Exclusion criteria
* Untreated brain metastasis. Treated brain metastases are allowed as long as symptoms have resolved off of steroids. * At least 4 weeks from any prior surgery or 2 weeks from radiation treatments. * Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Of Pharmacokinetically (PK) Guided Does Adjustment of 5-Fluorouracil (5-FU) In a Community Oncology Setting | From enrollment to the end of treatment at 8 weeks | The Feasibility Of Pharmacokinetically Guided Does Adjustment of 5-Fluorouracil In a Community Oncology Setting is Defined as 80% Success Rate among Patients Who Has Completed Four Sequential PK blood Draws with Subsequent Dose Adjustments During the Treatment with 5-FU based Drug Therapy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJasmine Huynh, MD
Inova Schar Cancer Institute
Outcome results
None listed