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CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer

A Phase I Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer and Good Performance Status

NCT01835041•Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of CPI-613 when given together with combination chemotherapy in treating patients with metastatic pancreatic cancer. Drugs used in chemotherapy, CPI-613, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of CPI-613 (6,8-bis\[benzylthio\]octanoic acid), when used in combination with modified leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (mFOLFIRINOX), in patients with metastatic pancreatic cancer. SECONDARY OBJECTIVES: I. To assess the safety of CPI-613/mFOLFIRINOX combination in patients with metastatic pancreatic cancer. II. To collect tissue for future genomic analyses. III. To obtain preliminary data on efficacy of treatment with CPI-613/mFOLFIRINOX. 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 and 3. Patients also receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for 6 months in the absence of disease progression or unacceptable toxicity.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically and cytologically confirmed metastatic pancreatic adenocarcinoma
•Eastern Cooperative Oncology Group (ECOG) performance status being 0-1
•Expected survival \> 2 months
•Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
•Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists
•At least 2 weeks must have elapsed from any prior surgery or hormonal therapy
•Granulocyte count \>= 1500/mm\^3
•White blood cell (WBC) \>= 3500 cells/mm\^3 or \>= 3.5 bil/L
•Platelet count \>= 100,000 cells/mm\^3 or \>= 100 bil/L
•Absolute neutrophil count (ANC) \>= 1500 cells/mm\^3 or \>= 1.5 bil/L
+7 more criteria

Exclusion Criteria

•Endocrine or acinar pancreatic carcinoma
•Previous radiotherapy for cerebral metastases, central nervous system (CNS) or epidural tumor
•Prior treatment with any chemotherapy for metastatic disease from pancreatic cancer
•Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 4 weeks prior to initiation of CPI-613 treatment
•Serious medical illness that would potentially increase patients' risk for toxicity
•Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
•Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown)
•Lactating females
•Fertile men unwilling to practice contraceptive methods during the study period
•Life expectancy less than 2 months
+10 more criteria

Locations (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Key Dates

Start Date

April 1, 2013

Primary Completion Date

February 28, 2017

Completion Date

March 16, 2023

Last Updated

July 12, 2023

Enrollment

ACTUAL participants

Conditions

Acinar Cell Adenocarcinoma of the PancreasDuct Cell Adenocarcinoma of the PancreasRecurrent Pancreatic CancerStage IV Pancreatic Cancer

Interventions

6,8-bis(benzylthio)octanoic acid

DRUG

oxaliplatin

DRUG

leucovorin calcium

DRUG

irinotecan hydrochloride

DRUG

fluorouracil

DRUG

laboratory biomarker analysis

OTHER

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COMPLETEDPHASE2

Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

NCT00031694

Acinar Cell Adenocarcinoma of the PancreasDuct Cell Adenocarcinoma of the Pancreas+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Pancreatic Cancer Diagnosis With FAPI-PET Imaging

Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

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