A Phase II Study of Dasatinib (NSC #732517) in Patients With Chemo-Sensitive Relapsed Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- 6 Week Progression Free Survival
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: dasatinib (Drug)
Outcomes
Primary Outcomes
6 Week Progression Free Survival
Time Frame: 6 weeks
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.
Secondary Outcomes
- Progression Free Survival (PFS)(Time from registration to progression (up to 3 years))
- Response to Therapy(Assessed every 2 cycles (up to 3 years))
- Overall Survival(Time from registration to death (up to 3 years))
- Number of Participants With Grade 3 or Higher Adverse Events(Assessed during treatment)