Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220155
Status:
COMPLETED
Last Update Posted:
2009-12-16
First Post:
2005-09-20
Brief Title:
Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2009-12
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:
To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated metastatic colorectal cancer
Detailed Description:
Previous lines of treatment recorded Adjuvant and palliative
Treatment will continue until clinical indication due to PD or toxicity or until completion of 6 cycles of gemcitabine whichever comes first
All patients will be assessed for toxicity and followed up for disease recurrenceprogression
The study will be divided into two accrual stages - the first consisting of 17 patients If 6 or more patients achieve tumour response or stabilisation in the first stage the second stage will commence accrual of a further 20 patients Hence the total planned accrual will be 37 patients
Treatment will continue until clinical indication due to PD or toxicity or until completion of 6 cycles of gemcitabine whichever comes first
All patients will be assessed for toxicity and followed up for disease recurrenceprogression
The study will be divided into two accrual stages - the first consisting of 17 patients If 6 or more patients achieve tumour response or stabilisation in the first stage the second stage will commence accrual of a further 20 patients Hence the total planned accrual will be 37 patients
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