Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262769
Status:
COMPLETED
Last Update Posted:
2012-07-17
First Post:
2005-12-06
Brief Title:
Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Gemcitabine Alone or in Combination With Cisplatin in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors A Multicentre Randomized Phase III Study
Status:
COMPLETED
Status Verified Date:
2012-07
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:
ABC-02
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors
PURPOSE This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors
PURPOSE This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine hydrochloride with vs without cisplatin
Secondary
Compare the progression-free survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center primary site of disease gallbladder vs bile ducts vs ampulla prior therapy photodynamic therapy PDT vs non-PDT therapy vs none ECOG performance status 0 vs 1 vs 2 and disease status locally advanced vs metastatic Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1½ hours on days 1 and 8 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 12 weeks and after finishing treatment
After completion of study treatment patients are followed periodically for at least 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
Primary
Compare the overall survival of patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine hydrochloride with vs without cisplatin
Secondary
Compare the progression-free survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center primary site of disease gallbladder vs bile ducts vs ampulla prior therapy photodynamic therapy PDT vs non-PDT therapy vs none ECOG performance status 0 vs 1 vs 2 and disease status locally advanced vs metastatic Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1½ hours on days 1 and 8 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 12 weeks and after finishing treatment
After completion of study treatment patients are followed periodically for at least 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
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 |
|---|---|---|---|
| CTA-212660005001 | None | None | None |
| CRUK-ABC-02 | None | None | None |
| EU-205103 | None | None | None |
| ISRCTN82956140 | None | None | None |
| EUDRACT-2004-004882-14 | None | None | None |