Phase 2
N=44
Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
Extensive Stage Small Cell Lung Cancer · Limited Stage Small Cell Lung Cancer · Recurrent Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00470054 ↗Enrolled (actual)
44
Serious AEs
31.8%
Results posted
Apr 2013
Primary outcome: Primary: 6 Week Progression Free Survival — 43 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dasatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Week Progression Free Survival |
43 | — |
| SECONDARY Progression Free Survival (PFS) |
5.9 | — |
| SECONDARY Response to Therapy |
0; 0; 7; 28; 8 | — |
| SECONDARY Overall Survival |
17 | — |
| SECONDARY Number of Participants With Grade 3 or Higher Adverse Events |
12 | — |
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.
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 = = 60 mL/min
- AST = 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
Data sourced from ClinicalTrials.gov (NCT00470054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.