Sunitinib, Irinotecan, Fluorouracil, and Leucovorin In Treating Patients With Advanced Stomach Cancer or Gastroesophageal Cancer

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT00524186
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • fluorouracil — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • sunitinib malate — DRUG
    Taken Orally
  • flow cytometry — OTHER
    Correlative Study
  • pharmacological study — OTHER
    Correlative Study

Study Details

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. 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 sunitinib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib when given together with irinotecan, fluorouracil, and leucovorin in treating patients with advanced stomach cancer or gastroesophageal cancer.

Key Dates

Start date
May 31, 2007
Status verified
Jun 2016
Primary completion
Aug 31, 2013
Completion
Apr 30, 2016

Study Design

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

Arms

  • Experimental: Oral Sunitinib
    Patients receive oral sunitinib malate on day -7 and then once daily on days 2-28 in course 1 and on days 1-28 in all subsequent courses

Primary Outcome Measure

Maximum tolerated dose of sunitinib malate when administered with FOLFIRI chemotherapy (i.e., irinotecan hydrochloride, fluorouracil, and leucovorin calcium) [ Time Frame: 30 days after treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-0001-

Find similar trials in Buffalo, NY

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
Roswell Park Cancer Institute· Buffalo, NY

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