Docetaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery - Full Text View

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00664105

Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 docetaxel and carboplatin together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

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

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Concurrent Chemoradiotherapy With Weekly Docetaxel, Carboplatin and Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel and Carboplatin for Locally Advanced Inoperable Non-Small Cell Lung Cancer (NSCLC)

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

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]
Safety and tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	February 2004
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine the overall survival of patients with unresectable stage IIIA or IIIB non-small cell lung cancer receiving concurrent chemoradiotherapy comprising docetaxel, carboplatin, and radiotherapy followed by consolidation chemotherapy comprising docetaxel and carboplatin.

Secondary

To determine the overall response rate in patients treated with this regimen.
To determine the time to disease progression in patients treated with this regimen.
To assess the safety and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Concurrent chemoradiotherapy (weeks 1-7): Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30 minutes on day 1. Patients also undergo radiotherapy once daily for 5 days a week. Treatment repeats weekly for 7 courses in the absence of disease progression or unacceptable toxicity.
Consolidation chemotherapy: Beginning three weeks later, responding patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 2 months, every 3 months for 2 years, every 4 months for 2 years, and then every 6 months thereafter.

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
- Stage IIIA or IIIB disease
- Non-metastatic, unresectable disease
Must have ≥ 1 site of unidirectionally measurable disease
No malignant pleural effusion (wet stage IIIB) or stage IV disease
No brain metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
ANC ≥ 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin > 9.0 g/dL
Creatinine ≤ 1.5 mg/dL
Creatinine clearance > 50 ml/min
Total bilirubin normal
Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:
- AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST and ALT normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception prior to, during, and for at least 3 months after completion of study therapy
FEV_1 > 800 mL
Must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry
Peripheral neuropathy < grade 2
No known hypersensitivity to drugs formulated with polysorbate 80
No other concurrent malignancy
No uncontrolled, clinically significant medical or psychiatric disorder
No weight loss ≥ 10% over the past 3 months

PRIOR CONCURRENT THERAPY:

No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for this disease
At least 3 weeks since prior formal exploratory thoracotomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664105

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Alan B. Sandler, MD

Vanderbilt-Ingram 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:	CDR0000584692, VU-VICC-THO-0319, VU-VICC-030269, VU-VICC-GIA12165
Study First Received:	April 19, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00664105
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
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009