Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003558
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin
Sponsor:
Academisch Ziekenhuis Maastricht
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Trial of Paclitaxel Carboplatin and Etoposide Vs 5-Fluorouracil and Folinic Acid in the Treatment of Patients With Adenocarcinoma of Unknown Primary Site
Status:
UNKNOWN
Status Verified Date:
2003-02
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 It is not yet known which combination chemotherapy regimen is more effective for cancer of unknown primary origin
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating patients with cancer of unknown primary origin
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating patients with cancer of unknown primary origin
Detailed Description:
OBJECTIVES
Compare the overall survival after treatment with paclitaxel carboplatin and etoposide and after treatment with fluorouracil and leucovorin calcium in patients with adenocarcinoma of unknown primary
Compare the response rates progression free survival toxicity profile and quality of life between the two regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center and presence or absence of liver metastases
Patients are randomly assigned to one of two treatment arms
Arm I Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 and oral etoposide on days 1-10 Treatment is repeated every 3 weeks for up to four courses
Arm II Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours weekly for 6 weeks Treatment is repeated every 7 weeks for up to two courses
Patients are followed every 3 months after treatment for 1 year or until death Quality of life questionnaires are completed at each follow-up
PROJECTED ACCRUAL Approximately 120-140 patients will be accrued for this study within 3 years
Compare the overall survival after treatment with paclitaxel carboplatin and etoposide and after treatment with fluorouracil and leucovorin calcium in patients with adenocarcinoma of unknown primary
Compare the response rates progression free survival toxicity profile and quality of life between the two regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center and presence or absence of liver metastases
Patients are randomly assigned to one of two treatment arms
Arm I Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 and oral etoposide on days 1-10 Treatment is repeated every 3 weeks for up to four courses
Arm II Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours weekly for 6 weeks Treatment is repeated every 7 weeks for up to two courses
Patients are followed every 3 months after treatment for 1 year or until death Quality of life questionnaires are completed at each follow-up
PROJECTED ACCRUAL Approximately 120-140 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| EU-98023 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066622 | REGISTRY | None | None |