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Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Small Cell Lung Cancer

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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 GroupRochester, Minnesota  55905