Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT02896907
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Pancreatic Adenocarcinoma
  • Recurrent Pancreatic Carcinoma
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Unresectable Pancreatic Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Ascorbic Acid — DIETARY_SUPPLEMENT
    Given IV

Study Details

This pilot clinical trial studies the side effects of ascorbic acid and combination chemotherapy in treating patients with pancreatic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Nutrients found in food and dietary supplements, such as ascorbic acid, may improve the tolerability of chemotherapy regimens. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may work better in treating patients with pancreatic cancer.

Key Dates

Start date
Oct 18, 2016
Status verified
Apr 2025
Primary completion
Mar 22, 2018
Completion
Mar 31, 2019

Study Design

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

Arms

  • Experimental: Treatment (FOLFIRINOX, ascorbic acid)
    Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Adverse Events as Determined by CTCAE Version 4.03 [ Time Frame: Up to 28 days after the last treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Philadelphia, PA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

Related Studies