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)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

November 30, 2005

Study Completion Date

November 30, 2005

Conditions
Pediatric Solid Tumors
Interventions
DRUG

Carboplatin

IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity

DRUG

Irinotecan

IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity

DRUG

Irinotecan

IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY