- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00323362
Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New Jersey
-
Hamilton, New Jersey, United States, 08690
- Cancer Institute of New Jersey at Hamilton
-
New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
New Brunswick, New Jersey, United States, 08903
- Saint Peter's University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gemcitabine hydrochloride and imatinib mesylate
|
1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
400 mg/day orally, given Days 1-5 and 8-12 every 21 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Who Meet Critieria for Response
Time Frame: 2 years
|
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. |
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression
Time Frame: 2 years
|
2 years
|
|
1-year Survival
Time Frame: 3 years
|
Accrual duration is 2 years with an additional year for assessment of 1-year survival.
Outcome measure time frame is about 3 years.
|
3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mika Sovak, MD, PhD, Rutgers Cancer Institute of New Jersey
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protein Kinase Inhibitors
- Gemcitabine
- Imatinib Mesylate
Other Study ID Numbers
- CDR0000539557
- P30CA072720 (U.S. NIH Grant/Contract)
- 030503 (Other Identifier: CINJ)
- 0220060014 (Other Identifier: UMDNJ IRB)
- NJ1505 (Other Identifier: CINJ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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