Gleevec Combined With Camptosar Plus Paraplatin in Previo... | NCT00193349

Studies
Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer

NCT00193349

Sponsor

SCRI Development Innovations, LLC

Status

Completed

Last Update Posted

Jun 28, 2010Estimated

Enrollment

Phase

Phase 2

Conditions

Lung Cancer

Interventions

Imatinib
Irinotecan
Carboplatin

Countries

Not provided

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

Jan 2008

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

Sep 2002

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 19, 2005Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2010

Last Update Posted Date

Jun 28, 2010Estimated

Name	Class
Novartis	INDUSTRY
Pharmacia and Upjohn	INDUSTRY

Description Module

Brief Summary

This study will evaluate combination chemotherapy for patients with extensive stage small cell lung cancer combined with the potentially useful growth inhibiting effects of Gleevec.

Detailed Description

Upon determination of eligibility, all patients will be receive:

Irinotecan + Carboplatin + Imatinib

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Small cell lung cancer with extensive stage disease confirmed by biopsy
Measurable or evaluable disease
Ability to perform activities of daily living with minimal assistance
Adequate bone marrow, liver and kidney
No active brain metastasis.
No previous chemotherapy or radiation therapy
Give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Limited stage disease (includes IA, IB, IIA, IIB, and IIIA)
Active brain metastasis
Age < 18 years old
History of a prior malignancy within three years
Women pregnant or lactating.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Anthony Greco, MD	SCRI Development Innovations, LLC	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17805064	Result	Spigel DR, Hainsworth JD, Simons L, Meng C, Burris HA 3rd, Yardley DA, Grapski R, Schreeder M, Mallidi PV, Greco FA; Minnie Pearl Cancer Research Network. Irinotecan, carboplatin, and imatinib in untreated extensive-stage small-cell lung cancer: a phase II trial of the Minnie Pearl Cancer Research Network. J Thorac Oncol. 2007 Sep;2(9):854-61. doi: 10.1097/JTO.0b013e31814617b7.

Measure	Description	Time Frame
Overall response rate
Response duration

Measure	Description	Time Frame
Time to progression
Overall toxicity

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D000068877	Imatinib Mesylate
D000077146	Irinotecan
D016190	Carboplatin

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

ID	Type	Description	Link
CSTI571BUS66
CPTAIV-0020-403

Name	Type	Description	Arm Group Labels	Other Names
Imatinib	Drug
Irinotecan	Drug
Carboplatin	Drug