Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer

NCT ID: NCT00470054

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2013-04-30

Brief Summary

This phase II trial is studying how well dasatinib works in treating patients with relapse small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVE I. Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.

SECONDARY OBJECTIVE II. Determine the objective response rate (complete and partial response) in patients treated with this drug.

III. Determine the overall survival of patients treated with this drug. IV. Determine the toxicity of this drug in these patients.

OUTLINE:

Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for 3 years.

Conditions

Extensive Stage Small Cell Lung Cancer; Limited Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (dasatinib)

Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

dasatinib

Intervention Type: DRUG

Given PO

Interventions

dasatinib

Given PO

Intervention Type: DRUG

Other Intervention Names

BMS-354825; Sprycel

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed small cell lung cancer (SCLC) (limited or extensive stage disease)
• Progressive or recurrent disease after an initial response to first-line treatment with a platinum-based chemotherapy with or without concurrent definitive radiotherapy to the chest (chemotherapy must have been completed at least 90 days prior to documentation of relapse)
• Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
• Lesions that are not considered measurable include the following:

• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural or pericardial effusion
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• Tumor lesions situated in a previously irradiated area, unless progression after radiotherapy is documented in these lesions
• No known brain metastases (previously treated brain metastases allowed provided they are neurologically stable for >= 4 weeks)
• ECOG performance status 0-1
• Platelet count >= 100,000/mm^3
• Bilirubin =< 1.5 times upper limit of normal (ULN)
• Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min
• AST =< 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• No significant cardiac disease, including any of the following:

• New York Heart Association class III-IV heart disease
• Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
• Prolonged QTc > 480 msec (Fridericia correction)
• Major conduction abnormality (unless a cardiac pacemaker is present)
• No more than 1 prior chemotherapy regimen
• No prior dasatinib or compounds of similar chemical composition or similar biologic therapeutic activity including, but not limited to, any inhibitors of SRC, BCR-ABL, c-KIT, EPHA2, or PDGFRB kinases
• At least 2 weeks since prior definitive or palliative radiotherapy (prior radiotherapy allowed in the context of combined modality treatment with curative intent for limited stage disease; prophylactic cranial radiotherapy; or palliative radiotherapy initially or at relapse)
• At least 2 weeks since prior surgery and recovered
• At least 1 week since prior and no concurrent agents with proarrhythmic potential
• At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers
• At least 1 week since prior and no concurrent grapefruit concentrate
• No concurrent palliative radiotherapy
• No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent chemotherapeutic or investigational agents
• Fertile patients must use effective contraception during and for >= 6 weeks after completion of study therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonius Miller

Role: PRINCIPAL_INVESTIGATOR

Cancer and Leukemia Group B

Locations

Cancer and Leukemia Group B

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2009-00467

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000543528

Identifier Type: -

Identifier Source: secondary_id

CALGB 30602

Identifier Type: OTHER

Identifier Source: secondary_id

CALGB-30602

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014236

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00467

Identifier Type: -

Identifier Source: org_study_id