Carboplatin, Irinotecan, and Radiation Therapy Followed By Docetaxel in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer

University of Miami

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Radiation: radiation therapy

Drug: irinotecan hydrochloride

Drug: Docetaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00449020

SCCC-2003049 (Other Identifier)

20030244

WIRB-20051708 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as carboplatin, irinotecan, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and irinotecan together with radiation therapy followed by docetaxel works in treating patients with newly diagnosed stage III non-small cell lung cancer.

Full description

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.

Enrollment

32 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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