Elderly NSCLC/D vs DP (JCOG0207) - Full Text View

Sponsors and Collaborators:	Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00190476

Purpose

To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

Condition	Intervention	Phase
Non-Small-Cell Lung Cancer	Drug: Weekly docetaxel alone Drug: Weekly docetaxel + cisplatin combination	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial Comparing Docetaxel-Cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-Small-Cell Lung Cancer(JCOG0207)

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:

overall survival

Secondary Outcome Measures:

Toxicity
Progression-free survival
Response rate
Symptom score

Estimated Enrollment:	230
Study Start Date:	April 2003
Estimated Study Completion Date:	April 2007

Detailed Description:

The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination.

Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

histologically or cytologically proven non-small-cell lung cancer
stage IV, or stage III disease ineligible for definitive radiotherapy
70 years or older
ECOG PS 0-1
Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
No prior surgery within 4 weeks before enrollment
No prior radiotherapy for primary tumor
No prior radiotherapy for metastatic lesions within 2 weeks before enrollment
Adequate organ function
Signed informed consent

Exclusion Criteria:

Symptomatic brain metastasis
Active another neoplasms
Severe SVC syndrome
Massive pericardial, pleural effusion, or ascites
Bone metastasis emergent for palliative radiotherapy or surgery
Uncontrollable systemic hypertension
Heart failure, Unstable angina, Myocardial infarction within 6 months
Uncontrollable diabetes
Active infection
Interstitial pneumonia/ Pulmonary fibrosis
Hypersensitivity for polysorbate 80
Systemic administration of corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190476

Show 29 Study Locations

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Akira Yokoyama, MD, PhD

Department of Internal Medicine, Niigata Cancer Center Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	JCOG0207, C000000146
Study First Received:	September 11, 2005
Last Updated:	May 31, 2007
ClinicalTrials.gov Identifier:	NCT00190476
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:

Elderly
advanced
non-small-cell lung cancer
cisplatin
docetaxel

weekly
combination
chemotherapy
randomized trial

Study placed in the following topic categories:

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

Lung Neoplasms
Lung Diseases
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
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009