Pancreatic Cancer Clinical Trial
Official title:
09.017 - A Phase I Study of Tolfenamic Acid With Gemcitabine and Radiation in Patients With Locally Advanced or Metastatic Pancreatic Cancer Requiring Definitive or Palliative Radiation Therapy
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.
This is a phase I, open-label, non-randomized, single-center, dose-escalation study which
utilizes tolfenamic acid in combination with gemcitabine and radiation in patients with
locally advanced or metastatic pancreatic malignancies which require definitive or
palliative radiation.
Non-steroidal anti-inflammatory drugs (NSAIDs) are known to have a variety of
anti-neoplastic mechanisms, including inhibition of cell growth, promotion of apoptosis and
inhibition of angiogenesis. Tolfenamic acid is an oral (NSAID) migraine medication which has
demonstrated anti-tumor activity in preclinical pancreatic models when used with Gem/XRT
(gemcitabine and radiation therapy) and as a single agent.
Each patient enrolled will receive tolfenamic acid in combination with Gem/XRT. Depending on
cohort assignment, patients will self-administer tolfenamic acid at either 200mg, 400mg,
600mg or 800mg three times per day. Gemcitabine will be administered intravenously at 400
mg/m2, every seven days for a maximum of 5 doses, starting with the second week of
tolfenamic acid administration. Radiation will be given 5 days per week (Monday-Friday) for
up to 5 ½ weeks for a maximum dose of 50.4 Gy, beginning with the second week of tolfenamic
acid administration.
A maximum of 24 patients will be enrolled in the dose escalation portion of the study. After
the maximum tolerated dose (MTD) of tolfenamic acid has been determined, patients will be
enrolled in an expansion cohort (at the MTD or the highest dose level achieved if the MTD is
not reached) to further assess safety and the anti-tumor response to treatment with
tolfenamic acid plus Gem/XRT.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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