AzTrials
AzTrials

Lung CancerPhase 2NCT00323362

Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer

A Phase 2 study testing gemcitabine hydrochloride and imatinib mesylate in people with Lung Cancer, run by Rutgers, The State University of New Jersey at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
gemcitabine hydrochloride and imatinib mesylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesUnited States
Study dates
Apr 2006to Oct 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell cancer
  • Recurrent disease after adjuvant treatment OR progressive disease after 1 prior treatment for recurrent or metastatic disease
  • Received at least 1 prior chemotherapy regimen and meets the following criteria:
  • No more than 1 prior chemotherapeutic regimen in the recurrent or metastatic setting
  • Patients who received prior chemotherapy in the adjuvant setting are eligible when 1 of the following criteria is met:
  • In first recurrence (after 1 prior regimen)
  • Received first-line chemotherapy in the recurrent setting after 2 prior regimens
  • Measurable disease
  • Must have ≥ 1 measurable target lesion outside prior radiotherapy field OR radiologic confirmation of disease progression within a prior radiotherapy field
  • No known or untreated brain metastases or carcinomatous meningitis
  • Clinically stable, treated brain metastases allowed provided it has been > 7 days since prior steroids

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Able to swallow oral medication
  • No concurrent medical condition that would preclude study compliance
  • No history of allergic reaction to compounds of similar chemical or biological composition to gemcitabine hydrochloride or imatinib mesylate
  • No uncontrolled illness that would preclude study compliance, including any of the following:
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia requiring therapy
  • Myocardial infarction within the past 6 months
  • Active infection
  • No New York Heart Association class III-IV congestive heart failure
  • No chronic liver disease (i.e., chronic active hepatitis, cirrhosis)
  • No HIV positivity
  • No other primary malignancies within the past 5 years, except carcinoma in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • At least 3 weeks since prior anti-vascular endothelial growth factor therapy and recovered
  • At least 3 weeks since prior radiotherapy and recovered
  • More than 28 days since prior and no other concurrent investigational or commercial agents
  • More than 2 weeks since prior major surgery
  • No prior gemcitabine hydrochloride or imatinib mesylate for metastatic disease
  • No prior tyrosine kinase inhibitor, except for gefitinib or erlotinib hydrochloride
  • No concurrent therapeutic warfarin (prophylactic warfarin therapy ≤ 1 mg daily allowed)
  • No other concurrent medications that would preclude study compliance
  • No concurrent chronic systemic corticosteroids

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: Phase II Study of Imatinib Mesylate and Gemcitabine for Recurrent/Metastatic Non-small Cell Lung Cancer (NSCLC)

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the response rate in patients with recurrent or metastatic non-small cell lung cancer treated with gemcitabine hydrochloride and imatinib mesylate.

Secondary

  • Assess time to progression in patients treated with this regimen.
  • Assess overall survival and 1-year survival of patients treated with this regimen.
  • Assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, nonrandomized, uncontrolled, open-label study.

Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Conditions
Lung Cancer
Being tested
gemcitabine hydrochloride, imatinib mesylate
Keywords
recurrent non-small cell lung cancer, stage IV non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabine hydrochlorideDrug

    1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.

  • imatinib mesylateDrug

    400 mg/day orally, given Days 1-5 and 8-12 every 21 days

Study groups in NCT00323362
Study groupRoleWhat they receive
Gemcitabine hydrochloride and imatinib mesylateExperimentalNot described
Receives: Drug: gemcitabine hydrochloride; Drug: imatinib mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients Who Meet Critieria for Response

    Response is considered Partial Response or Complete Response as per RECIST criteria.

    Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

    Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

    Measured: 2 years

Secondary outcomes (2)
  1. Time to Progression

    Measured: 2 years

  2. 1-year Survival

    Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionOct 2008
  4. Study completionOct 2008

Why it stopped: Toxicity

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323362
Sponsor's protocol ID
CDR0000539557
Other IDs
P30CA072720, 030503, 0220060014, NJ1505
Status last verified
Apr 2014
First submitted
7 Mar 2006
Last updated
22 May 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and imatinib mesylate in people with Lung Cancer, run by Rutgers, The State University of New Jersey at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Who Meet Critieria for Response (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in