Trial | NCT00190476  Report issue

Title

Elderly NSCLC/D vs DP (JCOG0207)
Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    docetaxel cisplatin ...

  • Study Participants

    230
To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
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.
Study Started
Apr 30
2003
Study Completion
Apr 30
2007
Last Update
Sep 12
2016
Estimate

Drug Weekly docetaxel alone

Drug Weekly docetaxel + cisplatin combination

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
No Results Posted