NCT01719926

Phase I Platinum Based Chemotherapy Plus Indomethacin

Phase I Study Evaluating Indomethacin in Combination With Platinum-based Chemotherapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Indomethacin	3 times per day from 2 days before until 5 days after chemotherapy. Escalating dosage each cohort.

Timeline

• Start date: 2012-09-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2012-11-01
• Last updated: 2017-08-18

Locations

4 sites across 2 countries: Netherlands, Switzerland