Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002887
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer
Sponsor:
Ottawa Regional Cancer Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER
Status:
UNKNOWN
Status Verified Date:
2001-10
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 is a way to kill more tumor cells
PURPOSE Phase I trial to study the effects of hydroxyurea plus combination chemotherapy in patients with non-small cell lung cancer
PURPOSE Phase I trial to study the effects of hydroxyurea plus combination chemotherapy in patients with non-small cell lung cancer
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose of hydroxyurea that can be given in combination with other chemotherapy regimens in patients with incurable non-small cell lung cancer II Determine the toxicity of this combination chemotherapy regimen in these patients III Observe the efficacy of hydroxyurea in patients with incurable non-small cell lung cancer refractory to front-line chemotherapy
OUTLINE This study seeks to estimate the maximum tolerated dose MTD of hydroxyurea in combination with other chemotherapy Groups of 3 patients take escalated doses of oral hydroxyurea three times weekly or daily throughout treatment with cisplatin plus per their previous regimen vinblastine vindesine vinorelbine or etoposide Treatment continues in responding and stable patients until 3 months beyond documentation of complete remission minimum 4 courses maximum of 6 courses beyond documentation of partial remission or 3 courses beyond documentation of stable disease Patients are followed every 3 weeks for 3 months every 6 weeks for 3 months then every 3 months until disease progression
PROJECTED ACCRUAL An anticipated 15-30 patients will be entered
OUTLINE This study seeks to estimate the maximum tolerated dose MTD of hydroxyurea in combination with other chemotherapy Groups of 3 patients take escalated doses of oral hydroxyurea three times weekly or daily throughout treatment with cisplatin plus per their previous regimen vinblastine vindesine vinorelbine or etoposide Treatment continues in responding and stable patients until 3 months beyond documentation of complete remission minimum 4 courses maximum of 6 courses beyond documentation of partial remission or 3 courses beyond documentation of stable disease Patients are followed every 3 weeks for 3 months every 6 weeks for 3 months then every 3 months until disease progression
PROJECTED ACCRUAL An anticipated 15-30 patients will be entered
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 |
|---|---|---|---|
| NCI-V96-1099 | None | None | None |
| CAN-OTT-9501 | None | None | None |