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Carboplatin and Irinotecan Concomitantly With Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel for Locally Advanced Non-Small Cell Lung Cancer (GIA 12177).


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

Thank you

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 CenterMiami, Florida  33136