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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00323362
• Other study ID #: CDR0000539557
• Secondary ID: P30CA07272003050
• Status: Terminated
• Phase: Phase 2
• First received: March 7, 2006
• Last updated: April 25, 2014
• Start date: April 2006
• Est. completion date: October 2008

Study information

• Verified date: April 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride
1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
• imatinib mesylate
400 mg/day orally, given Days 1-5 and 8-12 every 21 days

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Saint Peter's University Hospital	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	No
Secondary	Time to Progression		2 years	No
Secondary	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.	3 years	No