NCT00057473

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

April 2, 2003

Last Update Submit

April 7, 2011

Conditions

Neoplasms

Keywords

unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • estimate response rate

Secondary Outcomes (1)

  • evaluate safety

Study Arms (2)

Arm A

EXPERIMENTAL
Drug: carboplatin + irinotecan

Arm B

ACTIVE COMPARATOR
Drug: irinotecan

Interventions

carboplatin + irinotecanDRUG

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.

Also known as: Paraplatin
Arm A
irinotecanDRUG

Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.

Arm B

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
* children 1-21 years of age * confirmed diagnosis of measurable solid tumor, including brain tumor, which has progressed on or after standard therapy, or for which no effective standard therapy is known * at least 4 weeks since last dose of immunotherapy, radiotherapy, or chemotherapy * no more than 3 prior chemotherapies * no symptomatic brain metastases

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Orlando, Florida, United States

Location

Local Institution

Houston, Texas, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

CarboplatinIrinotecan

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 2, 2003

First Posted

April 3, 2003

Study Start

February 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations

US(2)