NCT00052949

Brief Summary

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2003

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

4.4 years

First QC Date

January 24, 2003

Last Update Submit

October 7, 2013

Conditions

Recurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients progression-free

    Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

    16 weeks

Secondary Outcomes (5)

  • Survival time

    From registration to death due to any cause, assessed up to 3 years

  • Time to disease progression

    From randomization to documentation of disease progression, assessed up to 3 years

  • Duration of response (complete response [CR] or partial response [PR])

    The date from which the patient's objective status if first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years

  • Time to treatment failure

    From the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 3 years

  • Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0

    Up to 3 years

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.

Drug: imatinib mesylateOther: laboratory biomarker analysis

Interventions

imatinib mesylateDRUG

Given orally

Treatment (imatinib mesylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (imatinib mesylate)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed small cell lung cancer (SCLC)
  • No mixed histology
  • Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed)
  • c-Kit positive by immunohistochemistry (at least 1+)
  • At least 1 unidimensionally measurable lesion
  • Longest diameter at least 20 mm
  • No uncontrolled CNS metastasis
  • Treated CNS metastasis allowed
  • Performance status - ECOG 0-2
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 9 g/dL
  • Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Direct bilirubin no greater than ULN
  • Creatinine no greater than 1.5 times ULN
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Alex Adjei

    North Central Cancer Treatment Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

May 1, 2003

Primary Completion

October 1, 2007

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)