Carboplatin and Irinotecan Concomitantly With Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel for Locally Advanced Non-Small Cell Lung Cancer (GIA 12177).
18 Years
N/A
Both
Lung Cancer
Trial Information
Carboplatin and Irinotecan Concomitantly With Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel for Locally Advanced Non-Small Cell Lung Cancer (GIA 12177).
OBJECTIVES:
Primary
- Determine the objective response rate in patients with newly diagnosed stage IIIA or
IIIB non-small cell lung cancer treated with concurrent carboplatin, irinotecan
hydrochloride, and radiotherapy followed by consolidation docetaxel.
Secondary
- Evaluate the safety, toxicity, and complications of this regimen in these patients.
- Evaluate the median survival, 1-year and 2-year survival, and time to tumor progression
in these patients.
OUTLINE:
- Chemoradiotherapy: Patients receive carboplatin IV over 30 minutes followed by
irinotecan hydrochloride IV over 90 minutes on day 1. Patients also undergo
radiotherapy once daily on days 1-5. Treatment repeats weekly for up to 7 courses in
the absence of disease progression or unacceptable toxicity.
- Consolidation chemotherapy: Beginning 3-4 weeks after completion of chemoradiotherapy,
patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for
up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 4 years and then
annually thereafter.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIA or IIIB disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by
conventional techniques or > 10 mm by spiral CT scan
- No clinically significant malignant pleural or pericardial effusion (i.e., stage IIIB
wet disease)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL
- Bilirubin normal
- Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:
- AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
- Creatinine < 2.0 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment
- No New York Heart Association class III-IV heart disease
- No history of serious cardiac disease not adequately controlled
- No documented myocardial infarction within the past 6 months
- No congestive heart failure
- No unstable angina
- No clinically significant arrhythmia
- No history of severe hypersensitivity reaction to drugs formulated with polysorbate
80
- No peripheral neuropathy > grade 1
- No other malignancy within the past 5 years other than skin cancer
PRIOR CONCURRENT THERAPY:
- More than 3 weeks since prior major surgery
- No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for
NSCLC
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response (complete response, partial response, overall response) as measured by RECIST criteria prior to course 1 and within 1 month after completion of course 3 of consolidation chemotherapy
Outcome Time Frame:
5.25 years
Safety Issue:
No
Principal Investigator
Luis E. Raez, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
University of Miami Sylvester Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
EPROST-20030244
NCT ID:
NCT00449020
Start Date:
January 2004
Completion Date:
January 2008
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
