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Tolfenamic Acid, Gemcitabine and Radiation for Locally Advanced or Metastatic Pancreatic Cancer Requiring Radiation

NCT02159248 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-04-28

No results posted yet for this study

Summary

The purposes of this study are to:

* Evaluate the safety and toxicity of tolfenamic acid when used with gemcitabine and radiation therapy in patients with locally advanced or metastatic pancreatic cancer.
* Determine the maximum-tolerated dose (MTD) of tolfenamic acid when used with gemcitabine and radiation in pancreatic cancer.
* Characterize the pharmacokinetic profile of tolfenamic acid when used with gemcitabine and radiation.
* Assess the anti-tumor response to tolfenamic acid when used with gemcitabine and radiation in patients with advanced pancreatic malignancies.

Conditions

Interventions

DRUG

Tolfenamic acid + gemcitabine + radiation

Cohort 1: 200mg of oral tolfenamic acid, three times per day for 6 1/2 weeks, in combination with weekly intravenous gemcitabine at 400mg/m2 for 5 doses and external beam radiation for 5 1/2 weeks (28 doses at 1.8 Gy/Fx/day). Cohort 2: 400mg of oral tolfenamic acid, three times per day for 6 1/2 weeks, in combination with weekly intravenous gemcitabine at 400mg/m2 for 5 doses and external beam radiation for 5 1/2 weeks (28 doses at 1.8 Gy/Fx/day). Cohort 3: 600mg of oral tolfenamic acid, three times per day for 6 1/2 weeks, in combination with weekly intravenous gemcitabine at 400mg/m2 for 5 doses and external beam radiation for 5 1/2 weeks (28 doses at 1.8 Gy/Fx/day). Cohort 4: 800mg of oral tolfenamic acid, three times per day for 6 1/2 weeks, in combination with weekly intravenous gemcitabine at 400mg/m2 for 5 doses and external beam radiation for 5 1/2 weeks (28 doses at 1.8 Gy/Fx/day).

Sponsors & Collaborators

  • Orlando Health, Inc.

    lead OTHER

Principal Investigators

  • Omar R Kayaleh, M.D. · Orlando Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-08-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02159248 on ClinicalTrials.gov