Vorinostat Plus Radiation Therapy in Pancreatic Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00831493
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemoradiation (Radiation Therapy) — RADIATION
    Dose of 50.4 Gy in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
  • Vorinostat — DRUG
    Starting Dose of 200 mg orally once daily, Monday to Friday, Weeks 1 to 6.

Study Details

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.

Key Dates

Start date
May 31, 2009
Status verified
Feb 2012
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat + Radiation Therapy
    Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation [ Time Frame: Toxicity assessment at 6 weeks following chemoradiation (6 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
UT MD Anderson Cancer Center· Houston, TX

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