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

Sponsored by:	Sylvester Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00449020

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: docetaxel Drug: irinotecan hydrochloride Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Docetaxel Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Carboplatin and Irinotecan Concomitantly With Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel for Locally Advanced Non-Small Cell Lung Cancer (GIA 12177).

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity/safety profile as measured by NCI CTCAE v 3.0 [ Designated as safety issue: Yes ]
Median survival [ Designated as safety issue: No ]
1-year survival [ Designated as safety issue: No ]
2-year survival [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	January 2004

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449020

Locations

United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136

Sponsors and Collaborators

Sylvester Cancer Center

Investigators

Study Chair:

Luis E. Raez, MD, FACP

Sylvester Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000535986, SCCC-2003049, SCCC-20030244, SCCC-20051708, AVENTIS-SCCC-2003049
Study First Received:	March 15, 2007
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00449020
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Irinotecan
Carboplatin
Carcinoma, Non-Small-Cell Lung
Camptothecin
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009