Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
18 Years
N/A
Both
Recurrent Small Cell Lung Cancer
Trial Information
Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
PRIMARY OBJECTIVES:
I. Determine the response rate, time to progression, and overall survival of patients with
recurrent small cell lung cancer treated with imatinib mesylate.
II. Correlate the presence of c-Kit mutations in tumor tissue with treatment response in
patients treated with this drug.
III. Correlate individual patient variation in clinical (toxicity and/or activity),
pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative
laboratory study results) responses to this drug with genetic differences in proteins
involved in drug response (transport, metabolism, and/or mechanism of action).
OUTLINE: This is a multicenter study. Patients are stratified according to length of prior
therapy (less than 3 months vs at least 3 months).
Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the
absence of disease progression or unacceptable toxicity.
*Patients are followed every 3 months until disease progression and then every 6 months for
up to 3 years after registration.
NOTE: *Patients who develop CNS metastasis as the only site of disease progression receive
therapeutic whole-brain radiotherapy and then resume study therapy.
PROJECTED ACCRUAL: A total of 41 patients for stratum I will be accrued within 21 months and
50 patients for stratum II will be accrued within 25 months for this study.
Inclusion Criteria:
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- No mixed histology
- Must have received only 1 prior treatment regimen (e.g., cyclophosphamide,
doxorubicin, and vincristine alternating with etoposide and cisplatin allowed)
- c-Kit positive by immunohistochemistry (at least 1+)
- At least 1 unidimensionally measurable lesion
- Longest diameter at least 20 mm
- No uncontrolled CNS metastasis
- Treated CNS metastasis allowed
- Performance status - ECOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
- Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Direct bilirubin no greater than ULN
- Creatinine no greater than 1.5 times ULN
- No unstable angina pectoris
- No uncontrolled congestive heart failure within the past 3 months unless ejection
fraction is greater than 40%
- No myocardial infarction within the past 3 months
- No uncontrolled infection
- No other malignancy within the past 3 years except skin cancer or localized prostate
cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months
after study participation
- See Disease Characteristics
- More than 3 weeks since prior chemotherapy
- More than 2 weeks since prior radiotherapy
- No concurrent radiotherapy(including palliative therapy for bone pain)
- Concurrent whole-brain radiotherapy for CNS progression allowed
- More than 3 weeks since prior major surgery
- No prior imatinib mesylate
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The proportion of patients progression-free
Outcome Description:
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Outcome Time Frame:
16 weeks
Safety Issue:
No
Principal Investigator
Alex Adjei
Investigator Role:
Principal Investigator
Investigator Affiliation:
North Central Cancer Treatment Group
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-01801
NCT ID:
NCT00052949
Start Date:
May 2003
Completion Date:
Related Keywords:
- Recurrent Small Cell Lung Cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| North Central Cancer Treatment Group | Rochester, Minnesota 55905 |
