Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00470054
• Date of registration: 03/05/2007
• Primary sponsor: Cancer and Leukemia Group B
• Public title: Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
• Scientific title: A Phase II Study of Dasatinib (NSC #732517, IND #73969) In Patients With Chemosensitive Relapsed Small Cell Lung Cancer
• Date of first enrolment: April 2007
• Target sample size: 45
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00470054
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Antonius Miller, MD
• Affiliation: Comprehensive Cancer Center Hematology/Oncology Wake Forest University

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Platelet count = 100,000/mm^3

- WBC = 1,500/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

- Fertile patients must use effective contraception during and for = 6 weeks after
completion of study therapy

- 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)

PRIOR CONCURRENT THERAPY:

- 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 PDGFRß 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Drug: dasatinib

Primary Outcome(s)

Progression-free survival [Time Frame: 6 weeks]

Secondary Outcome(s)

Overall survival [Time Frame: 4 years post treatment]

Response rate [Time Frame: Assessed every 2 cycles]

Toxicity [Time Frame: Assessed during treatment]

Secondary ID(s)

CALGB-30602

CDR0000543528

U10CA031946

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)