Vorinostat, Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Upper Gastrointestinal Cancer

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT00537121
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • fluorouracil — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • vorinostat — DRUG
    Taken Orally
  • pharmacological study — OTHER
    Correlative Study

Study Details

RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with irinotecan, fluorouracil, and leucovorin in treating patients with advanced upper gastrointestinal cancer.

Key Dates

First listed
Sep 28, 2007
Start date
Nov 30, 2006
Status verified
Jun 2013
Primary completion
Oct 31, 2012
Completion
Jun 30, 2013

Study Design

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

Primary Outcome Measure

Maximum tolerated dose (MTD) of vorinostat (SAHA) when administered continuously and intermittently with standard doses of irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) [ Time Frame: 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-0001-

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Esophageal cancerGastric cancerLiver cancer
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OncologyGI oncologyHepatology
By research site
Roswell Park Cancer Institute· Buffalo, NY

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