Overview

Elderly NSCLC/D vs DP (JCOG0207)

Status:
Terminated

Trial end date:
2007-04-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Japan Clinical Oncology Group

Collaborator:

Ministry of Health, Labour and Welfare, Japan

Treatments:

Cisplatin
Docetaxel

Criteria

Inclusion Criteria:

1. histologically or cytologically proven non-small-cell lung cancer

2. stage IV, or stage III disease ineligible for definitive radiotherapy

3. 70 years or older

4. ECOG PS 0-1

5. Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy

6. No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other
neoplasms

7. No prior surgery within 4 weeks before enrollment

8. No prior radiotherapy for primary tumor

9. No prior radiotherapy for metastatic lesions within 2 weeks before enrollment

10. Adequate organ function

11. Signed informed consent

Exclusion Criteria:

1. Symptomatic brain metastasis

2. Active another neoplasms

3. Severe SVC syndrome

4. Massive pericardial, pleural effusion, or ascites

5. Bone metastasis emergent for palliative radiotherapy or surgery

6. Uncontrollable systemic hypertension

7. Heart failure, Unstable angina, Myocardial infarction within 6 months

8. Uncontrollable diabetes

9. Active infection

10. Interstitial pneumonia/ Pulmonary fibrosis

11. Hypersensitivity for polysorbate 80

12. Systemic administration of corticosteroids