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Vorinostat Plus Radiation Therapy in Pancreatic Cancer

NCT00831493 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2012-02-28

Study results available
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Summary

Primary Endpoint:

To determine the maximum tolerated dose (MTD) of vorinostat + radiation therapy (RT) in patients with locally advanced pancreatic cancer (LAPC).

Secondary Endpoints:

1. To assess the efficacy of vorinostat + RT in patients with LAPC as estimated by median overall survival.
2. To determine the radiological response as assessed by regular computer tomography (CT) and/or dynamic contrast enhanced computer tomography (DCE-CT) among patients treated with vorinostat and RT.
3. To evaluate the occurrence of symptoms and correlate to disease progression and tolerance to treatment using the MD Anderson Symptom Inventory-Gastrointestinal Module (MDASI-GI) self-reporting tool.
4. To correlate serum cytokine levels with symptoms and treatment outcomes.

Conditions

Interventions

RADIATION

Chemoradiation (Radiation Therapy)

Dose of 50.4 Gy in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.

DRUG

Vorinostat

Starting Dose of 200 mg orally once daily, Monday to Friday, Weeks 1 to 6.

Sponsors & Collaborators

Principal Investigators

  • Sunil Krishnan, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00831493 on ClinicalTrials.gov