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

This study has been terminated.
(Toxicity)
Sponsor:
Collaborators:
Novartis
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00323362
First received: March 7, 2006
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: gemcitabine hydrochloride
Drug: imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Imatinib Mesylate and Gemcitabine for Recurrent/Metastatic Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Percentage of Patients Who Meet Critieria for Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Time to Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 1-year Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years.


Enrollment: 17
Study Start Date: April 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine hydrochloride and imatinib mesylate Drug: gemcitabine hydrochloride
1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
Drug: imatinib mesylate
400 mg/day orally, given Days 1-5 and 8-12 every 21 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323362

Locations
United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Novartis
Investigators
Principal Investigator: Mika Sovak, MD, PhD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00323362     History of Changes
Other Study ID Numbers: CDR0000539557, P30CA072720, 030503, 0220060014, NJ1505
Study First Received: March 7, 2006
Results First Received: November 18, 2013
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Imatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014