A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)

Sponsor
Bristol-Myers Squibb
Study ID
NCT00990912
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Pediatric Solid Tumors

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity
  • Irinotecan — DRUG
    IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity
  • Irinotecan — DRUG
    IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity

Study Details

The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.

Key Dates

Start date
Jan 31, 2004
Status verified
Oct 2009
Primary completion
Nov 30, 2005
Completion
Nov 30, 2005

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin
  • Experimental: Irinotecan (12 (9) mg/m²/day)
  • Active Comparator: Irinotecan (10 (10) mg/m²/day

Primary Outcome Measure

Assessment of safety and tolerability [ Time Frame: 22 months ]

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