Clinical trial NCT00323362: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Novartis
First posted: 2006-05-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Patients Who Meet Critieria for Response
timeFrame: 2 years
Secondary outcomes:
measure: Time to Progression
timeFrame: 2 years
measure: 1-year Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Cancer Institute of New Jersey at Hamilton
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Mika Sovak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: