Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Ireland Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075374

Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which docetaxel regimen is more effective for non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel in treating patients who have not previously received chemotherapy for unresectable stage IIIB or stage IV non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: docetaxel	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	A Multicenter, Randomized Phase II Study of Two Schedules of Taxotere (Weekly Versus Every 3 Weeks) in Elderly or Poor Performance (ECOG PS 2), Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer

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

Study Start Date:

October 2003

Detailed Description:

OBJECTIVES:

Primary

Compare the effects of two different schedules of docetaxel on the incidence of grade 3 and 4 toxic effects in older or poor performance chemotherapy-naïve patients with unresectable stage IIIB or IV non-small cell lung cancer.

Secondary

Compare the overall survival of patients treated with these regimens.
Compare the response rate in patients treated with these regimens.
Compare the incidence of serious adverse events in patients treated with these regimens.
Determine the quality of life of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 2 courses during study treatment, and then at study completion.

Patients are followed at 1 month and then every 2-3 months thereafter.

PROJECTED ACCRUAL: A total of 210-230 patients (105-115 per treatment arm) 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
- Unresectable stage IIIB or IV disease
No untreated brain or leptomeningeal metastases
- Treated patients must be neurologically stable and the adverse effects from prior therapy must be resolved to grade 2 or less after the completion of treatment
No symptomatic (i.e., requiring thoracentesis) pleural effusion
No clinically significant (i.e., grade 3 or greater) pericardial effusion

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2 (70 years of age and over) OR
ECOG 2 (under 70 years of age)

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 8.0 g/dL

Hepatic

Bilirubin normal
AST and ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase is no greater than ULN OR
Alkaline phosphatase no greater than 4 times ULN if ALT and AST are no greater than ULN

Renal

Not specified

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study participation
No grade 2 or greater peripheral neuropathy
No prior hypersensitivity reaction to taxanes or products containing polysorbate 80
No other active malignancy except carcinoma in situ of the cervix or basal cell skin cancer
No psychological, familial, sociological, or geographical condition that would preclude study treatment or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Recovered from prior radiotherapy (i.e., side effects resolved to grade 2 or less)
No concurrent radiotherapy

Surgery

More than 3 weeks since prior major surgery

Other

More than 30 days since prior anticancer investigational drugs
- Concurrent supportive care investigational agents allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075374

Locations

United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Ireland Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Afshin Dowlati, MD

Case Comprehensive 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:	CDR0000346070, CWRU-MSMC-1503, AVENTIS-GIA-12143, THERADEX-GIA-12143, MTSMC-LUN06
Study First Received:	January 9, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00075374
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent 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
Carcinoma, Non-Small-Cell Lung
Recurrence
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 13, 2009