Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Anne Noonan
Study ID
NCT04164069
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Colorectal Carcinoma
  • Bile Duct Cancer
  • Esophageal Cancer
  • Gall Bladder Cancer
  • Gastric Cancer
  • Metastatic Colorectal Carcinoma
  • Pancreatic Cancer
  • Small Bowel Adenocarcinoma
  • Stage II Colon Cancer
  • Stage II Rectal Cancer
  • Stage III Colon Cancer
  • Stage III Rectal Cancer
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IVC Colorectal Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Dasatinib — DRUG
    Given PO
  • Fluorouracil — DRUG
    Given IV
  • Leucovorin — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

This phase Ib trial studies side effects and best dose of dasatinib in preventing oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancers who are receiving FOLFOX regimen with or without bevacizumab. Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin (FOLFOX regimen), 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. However, the buildup of oxaliplatin in the cranial nerves can result in damage or the nerves. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Blocking these enzymes may reduce oxaliplatin-induced peripheral neuropathy.

Key Dates

First listed
Nov 15, 2019
Start date
Sep 2, 2020
Status verified
Apr 2024
Primary completion
Jun 22, 2023
Completion
Jun 22, 2023

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Prevention (dasatinib, mFOLFOX, bevacizumab)
    Patients receive oxaliplatin IV over 2 hours, leucovorin IV over 2 hours, fluorouracil slow IV push over 2-4 minutes followed by continuous infusion over 46 hours on days 1 and 15. Patients also receive dasatinib PO QD on days 14, 15, and 28 of cycle 1 and day 1 of cycle 2. Patients may receive bevacizumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to cycle 3 day 1 in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recommended phase II dose (RP2D) of dasatinib [ Time Frame: Up to 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By condition
Esophageal cancerGastric cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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