Capecitabine or 5-Fluorouracil in Combination With Irinotecan and Cisplatin in Patients With Solid Tumor Malignancies

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00215501
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    Orally twice a day for 14 days (dosage will vary)
  • 5-Fluorouracil (5-FU) — DRUG
    Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary
  • Irinotecan — DRUG
    Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period
  • Cisplatin — DRUG
    Intravenously weekly for 2 weeks followed by a one week rest period

Study Details

The purpose of this study is to test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good and bad) these have on patients with unresectable, advanced solid tumors.

Key Dates

Start date
Nov 30, 2001
Status verified
Oct 2018
Primary completion
Sep 30, 2005
Completion
Sep 30, 2008

Study Design

Enrollment
54 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Oral capecitabine
  • Experimental: Group B
    5-fluorouracil

Primary Outcome Measure

To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population. [ Time Frame: 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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