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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
imatinib mesylate
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey at Hamilton
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Saint Peter's University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine hydrochloride and imatinib mesylate

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Progression
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.

Full Information

First Posted
March 7, 2006
Last Updated
April 25, 2014
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00323362
Brief Title
Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
Official Title
Phase II Study of Imatinib Mesylate and Gemcitabine for Recurrent/Metastatic Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Toxicity
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine hydrochloride and imatinib mesylate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Description
400 mg/day orally, given Days 1-5 and 8-12 every 21 days
Primary Outcome Measure Information:
Title
Percentage of Patients Who Meet Critieria for Response
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Time to Progression
Time Frame
2 years
Title
1-year Survival
Description
Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika Sovak, MD, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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

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