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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT01835041
Phase
PHASE1
Status
Completed

Conditions

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 6,8-bis(benzylthio)octanoic acid — DRUG
    Given IV
  • oxaliplatin — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • fluorouracil — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Apr 30, 2013
Status verified
Jul 2023
Primary completion
Feb 28, 2017
Completion
Mar 16, 2023

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (6,8-bis[benzylthio]octanoic acid, mFOLFIRINOX)
    Patients receive 6,8-bis(benzylthio)octanoic acid 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.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 2 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Comprehensive Cancer Center of Wake Forest UniversityWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By research site
Comprehensive Cancer Center of Wake Forest University· Winston-Salem, NC

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