A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid Tumors

Part of paid clinical trials in Orlando, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00057473
Phase
PHASE2
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • carboplatin + irinotecan — DRUG
    Solution, IV, Carbopaltin AUC 4 mg/ml.min every 21 days; irinotecan 12 mg/m2/day x 10 days , Minimum of two cycles of chemotherapy projected to be up to 6.
  • irinotecan — DRUG
    Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.

Study Details

This clinical research study is being conducted to investigate the effectiveness of combining carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory solid tumors.

Key Dates

Start date
Feb 28, 2003
Status verified
Apr 2011
Primary completion
Feb 29, 2004
Completion
Feb 29, 2004

Study Design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Active Comparator: Arm B

Primary Outcome Measure

estimate response rate

Locations (2)

FacilityCityStateZIPSite coordinators
Local InstitutionOrlandoFlorida--
Local InstitutionHoustonTexas--

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