Text Size

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)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00990912
First received: October 5, 2009
Last updated: February 3, 2010
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Pediatric Solid Tumors
 Drug: Carboplatin
Drug: Irinotecan
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Document Long-term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects 1 - 21 Years of Age With Refractory Solid Tumors Who Have Experienced Clinical Benefit Following a Minimum of 6 Cycles of Therapy on BMS Protocol CA124-001 or BMS Protocol CA124-002

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Assessment of safety and tolerability [ Time Frame: 22 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment [ Time Frame: Every other cycle for 22 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carboplatin Drug: Carboplatin
IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity
Other Names:
  • Paraplatin
  • BMY-26575
Experimental: Irinotecan (12 (9) mg/m²/day) Drug: Irinotecan
IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity
Other Names:
  • Camptosar
  • Campto
Active Comparator: Irinotecan (10 (10) mg/m²/day Drug: Irinotecan
IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity
Other Names:
  • Camptosar
  • Campto

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy
  • Karnofsky score of at least 50 for subjects > 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger
  • Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies
  • Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002

Exclusion Criteria:

  • A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
  • Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study
  • Inadequate bone marrow and renal function
  • Concurrent receipt of Dilantin®(phenytoin), phenobarbital, primidone, Tegretol®(carbamazepine), Depacon®, Depakene®, Depakote®, and Deproic®(valproic acid)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990912

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00990912     History of Changes
Other Study ID Numbers: CA124-003
Study First Received: October 5, 2009
Last Updated: February 3, 2010
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Brazil: Ministry of Health
Chile: Instituto de Salud Publica de Chile
Costa Rica: Ministry of Health Costa Rica
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Mexico: Federal Commission for Sanitary Risks Protection
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Romania: Ministry of Public Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Irinotecan
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013