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Phase I Platinum Based Chemotherapy Plus Indomethacin

NCT01719926 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-08-18

No results posted yet for this study

Summary

Mesenchymal stem cells (MSCs) are present in the circulation of cancer patients, and are recruited to the stroma of both the primary tumor and metastasis. Recent preclinical research has shown that in response to platinum-based chemotherapy, MSCs secrete two specific platinum-induced fatty acids (PIFAs) which induce resistance to a broad spectrum of chemotherapies. The secreted PIFAs are the fatty acid oxo-heptadecatetraenoic acid (KHT) and the omega-3 fatty acid hexadecatetraenoic acid (16:4). These PIFAs are produced via the COX-1 pathway. COX inhibitors, including indomethacin. This phase 1 study explores the safety of combining indomethacin with platinum containing chemotherapy.

Conditions

  • Colorectal Neoplasms
  • Esophageal Neoplasms
  • Ovarian Neoplasms

Interventions

DRUG

Indomethacin

3 times per day from 2 days before until 5 days after chemotherapy. Escalating dosage each cohort.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • F.Y.F.L. de Vos, MD/PhD · UMC Utrecht

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Netherlands
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01719926 on ClinicalTrials.gov