NCT01011075

Brief Summary

This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients with advanced, non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

3 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

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
3 years until next milestone

Results Posted

Study results publicly available

July 3, 2015

Completed
Last Updated

July 3, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

October 14, 2009

Results QC Date

February 1, 2013

Last Update Submit

June 6, 2015

Conditions

Non-small Cell Lung Cancer

Keywords

Lung cancer,Non-small cell lung cancerNSCLCMetastaticGleevecelderly

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.

    6 months

Secondary Outcomes (3)

  • Overall Survival

    12 Months

  • Progression Free Survival

    12 months

  • Toxicities

    12 months

Study Arms (1)

Imatinib mesylate + Paclitaxel

EXPERIMENTAL

Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6

Drug: Imatinib mesylateDrug: Paclitaxel

Interventions

Imatinib mesylateDRUG

Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses(days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6

Also known as: Gleevec
Imatinib mesylate + Paclitaxel
PaclitaxelDRUG

Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Cycle length: 28 days Number of cycles: up to 6

Also known as: Taxol
Imatinib mesylate + Paclitaxel

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 70 years
  • Histologic or cytologic diagnosis of non-small cell lung cancer
  • At least one site of measurable disease, as defined by the modified RECIST criteria (See section 7.6)
  • Stage IIIB with pleural effusion or Stage IV disease. Includes patients who received surgery alone for early stage disease, now in relapse with advanced disease. Staging is according to the American Joint Committee on Cancer classification scheme, 6th edition.48
  • Adequate hepatic, renal and marrow function
  • Liver function tests: total bilirubin \< 1.25 x upper limit of normal (ULN), AST and ALT \< 2.5 x ULN, Creatinine \< 1.5 x ULN
  • Baseline absolute neutrophil count \> 1500/μL
  • Baseline platelet count \> 100,000/μL
  • ECOG Performance Status 0, 1 or 2 at the time of informed consent. (See Appendix 1)
  • Written, voluntary consent
  • Patients with reproductive potential must use an acceptable contraceptive method. Such methods include: 1) Male hormonal contraception; 2) Partner without reproductive potential, including post-menopausal status or history of tubal ligation; 3) Partner with intrauterine device (IUD) or contraceptive vaginal ring; 4) Partner takes oral contraceptive pill, wears contraceptive patch, or has contraceptive implant; 5) Routine use of barrier method, such as condoms or diaphragm, during sexual intercourse.

You may not qualify if:

  • Uncontrolled brain metastasis. Patients with known brain metastasis must have completed treatment with surgery, radiation or both. In addition, they must be off corticosteroids.
  • Symptomatic neuropathy (Grade 2 or higher)
  • Prior chemotherapy for advanced non-small cell lung cancer. (Prior adjuvant, neoadjuvant, or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence.)
  • Patient is \< 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention
  • Prior radiation therapy to \> 25% of bone marrow
  • Grade III/IV congestive heart failure, as defined by NYHA criteria, or myocardial infarction within 6 months.
  • Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or cirrhosis.
  • Major surgery two weeks prior to study treatment
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
  • Any condition requiring continuous administration of systemic corticosteroids.
  • The patient is on therapeutic anti-coagulation with warfarin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of New Mexico Cancer Center @ Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Univ. of Washington Fred Hutchinson Cancer Research Center (UW-FHCRC)

Seattle, Washington, 98109-1024, United States

Location

Related Publications (1)

  • Bauman JE, Eaton KD, Wallace SG, Carr LL, Lee SJ, Jones DV, Arias-Pulido H, Cerilli LA, Martins RG. A Phase II study of pulse dose imatinib mesylate and weekly paclitaxel in patients aged 70 and over with advanced non-small cell lung cancer. BMC Cancer. 2012 Oct 3;12:449. doi: 10.1186/1471-2407-12-449.

    PMID: 23033932RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsNeoplasm Metastasis

Interventions

Imatinib MesylatePaclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Julie E. Bauman, MD
Organization
University of Pittsburgh Cancer Institute
baumanje@upmc.edu
412-648-6507

Study Officials

  • Julie Bauman, MD

    University of New Mexico Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 14, 2009

First Posted

November 11, 2009

Study Start

August 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2012

Last Updated

July 3, 2015

Results First Posted

July 3, 2015

Record last verified: 2015-06

Locations

US(3)