Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248482
• Other study ID #: CDR0000445222
• Secondary ID: P30CA022453WSU-C
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2005
• Last updated: April 25, 2013
• Start date: February 2002
• Est. completion date: January 2008

Study information

• Verified date: April 2013
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back.

PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.

Description:

OBJECTIVES:

Primary

• Determine the 4-month progression-free survival rate in patients with c-kit positive, extensive stage small cell lung cancer treated with maintenance therapy comprising imatinib mesylate after induction therapy comprising irinotecan and cisplatin.

Secondary

• Determine the overall survival of patients treated with this regimen.

• Determine the tolerability of imatinib mesylate maintenance therapy in these patients.

• Determine the response rate in patients treated with irinotecan and cisplatin.

OUTLINE: This is a multicenter study.

• Induction therapy: Patients receive irinotecan IV over 90 minutes on days 1 and 8 and cisplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response (partial or complete) or stable disease proceed to maintenance therapy.

• Maintenance therapy: Patients receive oral imatinib mesylate twice daily for 6 months in the absence of disease progression or unacceptable toxicity. Some patients may continue to receive therapy for up to 1 year.

After completion of study treatment, patients are followed for 4 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2008
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer (SCLC)

• Extensive stage disease, defined by 1 of the following criteria:

• Disease extends beyond one hemithorax and regional lymph nodes

• Cytologically positive pleural effusion

• Meets 1 of the following criteria:

• Measurable disease, defined as = 1 unidimensionally measurable lesion outside the field of any prior radiotherapy

• Evaluable disease

• No history of untreated or symptomatic brain or leptomeningeal metastases

• Prior brain metastases allowed provided patient is neurologically stable for 2 weeks after completion of therapy

PATIENT CHARACTERISTICS:

Performance status

• SWOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 8 g/dL

Hepatic

• Bilirubin = 1.5 times upper limit of normal (ULN)

• Meets 1 of the following criteria:

• Alkaline phosphatase (AP) normal AND AST and ALT = 2.5 times ULN

• AP = 5 times ULN AND AST and ALT normal

• No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis)

Renal

• Creatinine normal OR

• Creatinine clearance = 65 mL/min

Cardiovascular

• No uncontrolled congestive heart failure

• No uncontrolled angina

• No myocardial infarction and/or stroke within the past 3 months

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No peripheral neuropathy = grade 2

• No symptomatic edema from any etiology

• No known HIV positivity

• No other serious medical illness

• No other malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

• No history of dementia, active psychiatric disorder, or other condition that would preclude study compliance or ability to take oral medication on a daily basis

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy for SCLC

Endocrine therapy

• No concurrent routine systemic corticosteroids

Radiotherapy

• See Disease Characteristics

• At least 2 weeks since prior palliative radiotherapy

Surgery

• More than 2 weeks since prior major surgery

Other

• No concurrent therapeutic anticoagulation with warfarin

• Concurrent low molecular weight heparin allowed provided regimen was initiated = 2 weeks prior to study entry

• No other concurrent participation in another study of an investigational agent

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Cisplatin
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
• Gleevec™
Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.
• irinotecan
Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI), Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		at 4 months	No
Secondary	Overall survival		at least 4 months after discontinuation of treatment	No
Secondary	Tolerability of Gleevec maintenance therapy		30 days after completion of study treatment	Yes
Secondary	Response rate as measured by RECIST at		Baseline and every 8 weeks during study treatment	No