NCT00193349

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Sep 2002

Typical duration for phase_2 lung-cancer

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

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 28, 2010

Status Verified

January 1, 2008

Enrollment Period

5.3 years

First QC Date

September 12, 2005

Last Update Submit

June 24, 2010

Conditions

Outcome Measures

Primary Outcomes (2)

  • Overall response rate

  • Response duration

Secondary Outcomes (2)

  • Time to progression

  • Overall toxicity

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Imatinib MesylateIrinotecanCarboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesCamptothecinAlkaloidsCoordination Complexes

Study Officials

  • Anthony Greco, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

September 1, 2002

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 28, 2010

Record last verified: 2008-01