Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Study of Dasatinib (NSC #732517) in Patients With Chemo-Sensitive Relapsed Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470054
• Other study ID #: NCI-2009-00467
• Secondary ID: NCI-2009-00467CD
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2007
• Last updated: April 14, 2015
• Start date: April 2007
• Est. completion date: April 2013

Study information

• Verified date: June 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2013
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Limited Stage Small Cell Lung Cancer
• Lung Neoplasms
• Recurrent Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• dasatinib
Given PO

Locations

Country	Name	City	State
United States	Cancer and Leukemia Group B	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Week Progression Free Survival	Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method.; Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.	6 weeks	No
Secondary	Progression Free Survival (PFS)	PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.; Progression is defined as in the primary outcome measure.	Time from registration to progression (up to 3 years)	No
Secondary	Response to Therapy	Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.	Assessed every 2 cycles (up to 3 years)	No
Secondary	Overall Survival	Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.	Time from registration to death (up to 3 years)	No
Secondary	Number of Participants With Grade 3 or Higher Adverse Events	The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity.; Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.	Assessed during treatment	Yes