A Phase II Study of Carboplatin Plus Irinotecan Versus Ir... | NCT00057473

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

NCT00057473

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Apr 14, 2011Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Neoplasms

Interventions

carboplatin + irinotecan
irinotecan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Feb 2004Actual

Completion Date

Feb 2004Actual

First Submitted Date

Apr 2, 2003

First Submission Date that Met QC Criteria

Apr 2, 2003

First Posted Date

Apr 3, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 3, 2010

Certification/Extension First Submitted that Passed QC Review

Feb 3, 2010

Certification/Extension First Posted Date

Feb 5, 2010Estimated

Last Update Submitted Date

Apr 7, 2011

Last Update Posted Date

Apr 14, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental		Drug: carboplatin + irinotecan
Arm B	Active Comparator		Drug: irinotecan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
estimate response rate

Measure	Description	Time Frame
evaluate safety

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Orlando	Florida		United States
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016190	Carboplatin
D000077146	Irinotecan

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D002166	Camptothecin
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided