Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003072
Status:
COMPLETED
Last Update Posted:
2012-09-21
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic Ovarian Cancer or Non-small Cell Lung Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Amifostine Ethyol as a Protectant in Metastatic Ovarian and Non-Small Cell Lung Cancer in PaclitaxelCarboplatin-Treated Patients A Comparative Trial
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
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 and giving the drugs in different combinations may kill more tumor cells
PURPOSE Randomized phase II double-blinded trial to study the effectiveness of paclitaxel and carboplatin given with either amifostine or placebo in patients with metastatic stage III or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer
PURPOSE Randomized phase II double-blinded trial to study the effectiveness of paclitaxel and carboplatin given with either amifostine or placebo in patients with metastatic stage III or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine whether patients with metastatic ovarian and non-small cell lung cancer receiving carboplatin and paclitaxel have significantly fewer neuropathic events when treated with amifostine
OUTLINE This is a randomized parallel group double blind controlled study Patients are randomized to either the amifostine or control group All patients receive intravenous paclitaxel over 3 hours followed by carboplatin once every 3 weeks for 6 cycles Patients who are randomized to the amifostine group receive intravenous amifostine administered as a 15 minute infusion 30 minutes prior to paclitaxel therapy Patients randomized to the control group receive an intravenous placebo solution Patients are discontinued from the study if they have disease progression or unacceptable toxic effects after 2 cycles of treatment Patients are followed monthly for 8 months post treatment
PROJECTED ACCRUAL A total of 80 patients will be accrued 40 with advanced ovarian cancer and 40 with advanced non-small cell lung cancer within 2 years
OUTLINE This is a randomized parallel group double blind controlled study Patients are randomized to either the amifostine or control group All patients receive intravenous paclitaxel over 3 hours followed by carboplatin once every 3 weeks for 6 cycles Patients who are randomized to the amifostine group receive intravenous amifostine administered as a 15 minute infusion 30 minutes prior to paclitaxel therapy Patients randomized to the control group receive an intravenous placebo solution Patients are discontinued from the study if they have disease progression or unacceptable toxic effects after 2 cycles of treatment Patients are followed monthly for 8 months post treatment
PROJECTED ACCRUAL A total of 80 patients will be accrued 40 with advanced ovarian cancer and 40 with advanced non-small cell lung cancer within 2 years
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-V97-1334 | None | None | None |
| UCSF-H57841348101A | None | None | None |
| ALZA-UCSF-H57841348101A | None | None | None |