Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006116
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2000-08-03
Brief Title:
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
First Line Treatment of Stage IIIbIV Non Small Cell NSC Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine
Status:
UNKNOWN
Status Verified Date:
2000-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining cisplatin with gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining cisplatin with gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of the combination of cisplatin and gemcitabine in terms of response rate and progression free survival in patients with stage IIIB or IV non-small cell lung cancer II Evaluate this treatment regimen in terms of toxicity and quality of life in these patients
OUTLINE This is a multicenter study Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients with no disease progression following 6 courses of therapy receive an additional 6 courses of therapy Quality of life is assessed prior to each course and then every 3 months Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 37-83 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients with no disease progression following 6 courses of therapy receive an additional 6 courses of therapy Quality of life is assessed prior to each course and then every 3 months Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 37-83 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20026 | None | None | None |
| FRE-GERCOR-B98-1 | None | None | None |