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Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors (ABC-02)

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
cisplatin
gemcitabine hydrochloride
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring cholangiocarcinoma of the extrahepatic bile duct, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, cholangiocarcinoma of the gallbladder, recurrent gallbladder cancer, unresectable gallbladder cancer, metastatic extrahepatic bile duct cancer, metastatic gallbladder cancer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma Intra- or extra-hepatic disease allowed Unresectable locally advanced, recurrent, or metastatic disease No brain metastases PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL (transfusion allowed) WBC ≥ 3,000/mm^3 Hepatic AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin ≤ 1.5 times ULN Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present) Adequate biliary drainage No unresolved biliary tract obstruction Renal Creatinine < 1.5 times ULN Urea < 1.5 times ULN Glomerular filtration rate (GFR) ≥ 45 mL/min If GFR < 60 mL/min, isotope EDTA confirmation of adequate renal function is required Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No active, uncontrolled infection No other severe or uncontrolled systemic disease No other malignancy within the past 5 years except nonmetastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection No psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Chemotherapy At least 6 months since prior adjuvant chemotherapy No prior gemcitabine hydrochloride No prior cisplatin No prior systemic chemotherapy for locally advanced or metastatic disease except low-dose radiosensitizing chemotherapy in conjunction with radiotherapy Radiotherapy Prior radiotherapy for localized disease allowed provided there is clear evidence of disease progression afterwards Surgery Prior curative surgery allowed provided there is evidence of nonresectable disease relapse requiring systemic chemotherapy Other Recovered from all prior therapies Prior photodynamic therapy (PDT) allowed provided it was given for localized disease only (with no evidence of metastatic disease) and resulted in subsequent disease progression after completion of therapy OR to relieve biliary obstruction in the presence of metastatic disease PDT must have been completed ≥ 4 weeks ago At least 4 weeks since prior investigational agents No other concurrent, curative anticancer therapy

Sites / Locations

  • Basingstoke and North Hampshire NHS Foundation Trust
  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
  • Addenbrooke's Hospital
  • Cumberland Infirmary
  • Gloucestershire Oncology Centre at Cheltenham General Hospital
  • Derbyshire Royal Infirmary
  • Princess Alexandra Hospital
  • Gloucestershire Royal Hospital
  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
  • Leeds Cancer Centre at St. James's University Hospital
  • Helen Rollason Cancer Care Centre at North Middlesex Hospital
  • Royal Marsden - London
  • Hammersmith Hospital
  • UCL Cancer Institute
  • University College of London Hospitals
  • Maidstone Hospital
  • Clatterbridge Centre for Oncology
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Nottingham City Hospital
  • Portsmouth Oncology Centre at Saint Mary's Hospital
  • Cancer Research Centre at Weston Park Hospital
  • Belfast City Hospital Trust Incorporating Belvoir Park Hospital
  • Aberdeen Royal Infirmary
  • Velindre Cancer Center at Velindre Hospital
  • Glan Clwyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A - Gemcitabine

B - Gemcitabine and Cisplatin

Arm Description

Gemcitabine alone

Gemcitabine and Cisplatin

Outcomes

Primary Outcome Measures

Overall Survival
From date of randomisation till date of death or last date of follow-up (up to 5 years)

Secondary Outcome Measures

Progression-free survival
From date of randomisation till date of death or last date of follow-up (up to 5 years)
Quality of life
Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically
Toxicity
Toxicity as measured by NCI CTC periodically. The proportion of patients who experience a toxicity of grade 3 or 4 will be compared between the two arms of the trial.

Full Information

First Posted
December 6, 2005
Last Updated
July 16, 2012
Sponsor
University College, London
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00262769
Brief Title
Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors
Acronym
ABC-02
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Keywords
cholangiocarcinoma of the extrahepatic bile duct, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, cholangiocarcinoma of the gallbladder, recurrent gallbladder cancer, unresectable gallbladder cancer, metastatic extrahepatic bile duct cancer, metastatic gallbladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - Gemcitabine
Arm Type
Experimental
Arm Description
Gemcitabine alone
Arm Title
B - Gemcitabine and Cisplatin
Arm Type
Experimental
Arm Description
Gemcitabine and Cisplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CDDP, cis-diamminedichloroplatinum(II), cisplatinum
Intervention Description
25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
Gemzar
Intervention Description
1000mg/m2 in 250-500mls 0.9% saline over 30 mins by intravenous infusions on day 1, 8 and 15 (Arm A only) of each 28 (Arm A) or 21 (Arm B) day cycle.
Primary Outcome Measure Information:
Title
Overall Survival
Description
From date of randomisation till date of death or last date of follow-up (up to 5 years)
Time Frame
From date of randomisation till date of death or last date of follow-up (up to 5 years)
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
From date of randomisation till date of death or last date of follow-up (up to 5 years)
Time Frame
From date of randomisation till date of death or last date of follow-up (up to 5 years)
Title
Quality of life
Description
Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically
Time Frame
Before and 12 weeks after completion of treatment
Title
Toxicity
Description
Toxicity as measured by NCI CTC periodically. The proportion of patients who experience a toxicity of grade 3 or 4 will be compared between the two arms of the trial.
Time Frame
During treatment and follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma Intra- or extra-hepatic disease allowed Unresectable locally advanced, recurrent, or metastatic disease No brain metastases PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL (transfusion allowed) WBC ≥ 3,000/mm^3 Hepatic AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin ≤ 1.5 times ULN Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present) Adequate biliary drainage No unresolved biliary tract obstruction Renal Creatinine < 1.5 times ULN Urea < 1.5 times ULN Glomerular filtration rate (GFR) ≥ 45 mL/min If GFR < 60 mL/min, isotope EDTA confirmation of adequate renal function is required Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No active, uncontrolled infection No other severe or uncontrolled systemic disease No other malignancy within the past 5 years except nonmetastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection No psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Chemotherapy At least 6 months since prior adjuvant chemotherapy No prior gemcitabine hydrochloride No prior cisplatin No prior systemic chemotherapy for locally advanced or metastatic disease except low-dose radiosensitizing chemotherapy in conjunction with radiotherapy Radiotherapy Prior radiotherapy for localized disease allowed provided there is clear evidence of disease progression afterwards Surgery Prior curative surgery allowed provided there is evidence of nonresectable disease relapse requiring systemic chemotherapy Other Recovered from all prior therapies Prior photodynamic therapy (PDT) allowed provided it was given for localized disease only (with no evidence of metastatic disease) and resulted in subsequent disease progression after completion of therapy OR to relieve biliary obstruction in the presence of metastatic disease PDT must have been completed ≥ 4 weeks ago At least 4 weeks since prior investigational agents No other concurrent, curative anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Bridgewater
Organizational Affiliation
University College London (UCL) Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Basingstoke and North Hampshire NHS Foundation Trust
City
Basingstoke
State/Province
England
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
State/Province
England
ZIP/Postal Code
CA2 7HY
Country
United Kingdom
Facility Name
Gloucestershire Oncology Centre at Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Princess Alexandra Hospital
City
Essex
State/Province
England
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
State/Province
England
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Helen Rollason Cancer Care Centre at North Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Royal Marsden - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
State/Province
England
ZIP/Postal Code
W12 OHS
Country
United Kingdom
Facility Name
UCL Cancer Institute
City
London
State/Province
England
ZIP/Postal Code
WC1E 6DD
Country
United Kingdom
Facility Name
University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Portsmouth Oncology Centre at Saint Mary's Hospital
City
Portsmouth Hants
State/Province
England
ZIP/Postal Code
PO3 6AD
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20375404
Citation
Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
Results Reference
result

Learn more about this trial

Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors

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