CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT02232152|
Recruitment Status : Active, not recruiting
First Posted : September 5, 2014
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mucinous Adenocarcinoma of the Colon Mucinous Adenocarcinoma of the Rectum Recurrent Colon Cancer Recurrent Rectal Cancer Signet Ring Adenocarcinoma of the Colon Signet Ring Adenocarcinoma of the Rectum Stage IIIA Colon Cancer Stage IIIA Rectal Cancer Stage IIIB Colon Cancer Stage IIIB Rectal Cancer Stage IIIC Colon Cancer Stage IIIC Rectal Cancer Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer||Drug: 6,8-bis(benzylthio)octanoic acid Drug: fluorouracil Other: pharmacological study Other: laboratory biomarker analysis||Phase 1|
I. To determine the maximum tolerated dose (MTD) of CPI-613 (6,8-bis[benzylthio]octanoic acid), when used in combination with 5-FU (fluorouracil), in patients with non-resectable metastatic colorectal cancer who have failed FOLFOX (leucovorin calcium, fluorouracil and oxaliplatin), FOLFIRI (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) and, if Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type, then a epidermal growth factor receptor (EGFR) inhibitor-based regimen.
I. To assess the pharmacokinetic (PK), safety and efficacy of various doses of CPI-613, when used in combination with 5-FU, in patients with non-resectable metastatic colorectal cancer.
OUTLINE: This is a dose-escalation study of 6,8-bis(benzylthio)octanoic acid.
Patients receive 6,8-bis(benzylthio)octanoic acid intravenously (IV) over 2 hours on days 1-4 and fluorouracil IV over 46 hours on days 2-4. Courses repeat every 2 weeks for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Trial of Fluorouracil (5-FU) + CPI-613 Combination in Previously Treated Metastatic Colorectal Cancer Patients|
|Actual Study Start Date :||January 6, 2015|
|Actual Primary Completion Date :||February 19, 2019|
|Estimated Study Completion Date :||August 2022|
Experimental: Treatment (6,8-bis(benzylthio)octanoic acid, fluorouracil)
Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-4 and fluorouracil IV over 46 hours on days 2-4. Courses repeat every 2 weeks for 6 months in the absence of disease progression or unacceptable toxicity.
Drug: 6,8-bis(benzylthio)octanoic acid
Other: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
- MTD of 6,8-bis(benzylthio)octanoic acid in combination with fluorouracil based on the incidence of dose-limiting toxicities graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 2 weeks ]
- Incidence of toxicity of 6,8-bis(benzylthio)octanoic acid and fluorouracil combination graded according to NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ]Examine toxicities by assessing each toxicity by grade.
- PK parameters (maximum observed concentration, area under the curve, half-life, elimination rate constant, drug clearance, and volume of distribution) of 6,8-bis(benzylthio)octanoic acid in plasma samples [ Time Frame: Week 1: days 1 and 4 before infusion of 6,8-bis(benzylthio)octanoic acid and at 30 minutes, 1, 1.5, 2, 4, 6 and 8 (optional) hours after the completion of infusion ]
- Progression-free survival (PFS) [ Time Frame: Time from the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression, assessed up to 3 years ]Plot a PFS curve using Kaplan-Meier methods, examine median PFS.
- Overall response rate (ORR) (i.e., sum of complete response [CR] and partial response [PR]) [ Time Frame: Up to 3 years ]Assess ORR and its 95% confidence interval.
- Disease control rate (DCR) (i.e., sum of CR, PR, and stable disease) [ Time Frame: Up to 3 years ]Assess DCR and its 95% confidence interval.
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): NCT02232152
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Caio Rocha Lima, MD||Wake Forest University Health Sciences|