Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002949
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
1999-11-01
Brief Title:
Vinorelbine and Paclitaxel Plus Radiation Therapy in Treating Patients With Advanced Cancer Arising in the Pelvis
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Phase I Study of Concomitant Chemoradiotherapy With Vinorelbine and Paclitaxel in Patients With Advanced Pelvic Malignancies
Status:
COMPLETED
Status Verified Date:
2013-09
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 radiation therapy with chemotherapy with may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of chemotherapy with vinorelbine and paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the pelvis
PURPOSE Phase I trial to study the effectiveness of chemotherapy with vinorelbine and paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the pelvis
Detailed Description:
OBJECTIVES I Assess the toxic effects of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation therapy II Determine the Maximum Tolerated Dose MTD of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation therapy III Access the toxic effects of paclitaxel given weekly in combination with the regimen determined to be the MTD of vinorelbine IV Determine the MTD of paclitaxel given weekly in combination with the regimen determined to be the MTD of vinorelbine
OUTLINE Part I Vinorelbine IV bolus is administered over 8-10 minutes on day 1 prior to radiation therapy Whole pelvic radiation treatment is given on days 1-5 followed by 2 days of rest The treatment volume encompasses all suspected pelvic disease with a minimum of 1 cm margin Cycles repeat weekly Dose of vinorelbine is escalated in cohorts of at least 3 patients until maximum tolerated dose MTD is determined Part II Paclitaxel is infused over 1 hour immediately following vinorelbine at the MTD as determined in part I Dose of paclitaxel is escalated in cohorts of at least 3 patients until the MTD is determined At least 6 patients are treated at the MTD for both parts I and II of the study Patients are followed for late and chronic toxicities
PROJECTED ACCRUAL Projected accrual is 12 patients per year for approximately 3 years
OUTLINE Part I Vinorelbine IV bolus is administered over 8-10 minutes on day 1 prior to radiation therapy Whole pelvic radiation treatment is given on days 1-5 followed by 2 days of rest The treatment volume encompasses all suspected pelvic disease with a minimum of 1 cm margin Cycles repeat weekly Dose of vinorelbine is escalated in cohorts of at least 3 patients until maximum tolerated dose MTD is determined Part II Paclitaxel is infused over 1 hour immediately following vinorelbine at the MTD as determined in part I Dose of paclitaxel is escalated in cohorts of at least 3 patients until the MTD is determined At least 6 patients are treated at the MTD for both parts I and II of the study Patients are followed for late and chronic toxicities
PROJECTED ACCRUAL Projected accrual is 12 patients per year for approximately 3 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-G97-1156 | None | None | None |
| UCCRC-8270 | None | None | None |