Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005825
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
Raghu Nandan MD Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Trans Retinoic Acid Vesanoid With Chemotherapy in Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2003-07
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 combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the response rate and duration of response to mitomycin vinorelbine and cisplatin plus tretinoin in patients with stage IIIB or IV non-small cell lung cancer
Determine the toxicity of this treatment regimen in these patients
Determine survival of these patients with this treatment regimen
OUTLINE Patients receive tretinoin orally twice daily for 4 days starting days 1 and 8 cisplatin IV over 2 hours and vinorelbine IV on days 1 and 8 and mitomycin IV courses 1 and 3 on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL At total of 15-46 patients will be accrued for this study
Determine the response rate and duration of response to mitomycin vinorelbine and cisplatin plus tretinoin in patients with stage IIIB or IV non-small cell lung cancer
Determine the toxicity of this treatment regimen in these patients
Determine survival of these patients with this treatment regimen
OUTLINE Patients receive tretinoin orally twice daily for 4 days starting days 1 and 8 cisplatin IV over 2 hours and vinorelbine IV on days 1 and 8 and mitomycin IV courses 1 and 3 on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL At total of 15-46 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1587 | None | None | None |
| NANDAN-VES-024 | None | None | None |