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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)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00262769
First received: December 6, 2005
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From date of randomisation till date of death or last date of follow-up (up to 5 years) ] [ Designated as safety issue: No ]
    From date of randomisation till date of death or last date of follow-up (up to 5 years)


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From date of randomisation till date of death or last date of follow-up (up to 5 years) ] [ Designated as safety issue: No ]
    From date of randomisation till date of death or last date of follow-up (up to 5 years)

  • Quality of life [ Time Frame: Before and 12 weeks after completion of treatment ] [ Designated as safety issue: No ]
    Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically

  • Toxicity [ Time Frame: During treatment and follow-up ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 324
Study Start Date: May 2005
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A - Gemcitabine
Gemcitabine alone
Drug: gemcitabine hydrochloride
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.
Other Name: Gemzar
Experimental: B - Gemcitabine and Cisplatin
Gemcitabine and Cisplatin
Drug: cisplatin
25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins
Other Names:
  • CDDP
  • cis-diamminedichloroplatinum(II)
  • cisplatinum
Drug: gemcitabine hydrochloride
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.
Other Name: Gemzar

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262769

Locations
United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Cumberland Infirmary
Carlisle, England, United Kingdom, CA2 7HY
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Princess Alexandra Hospital
Essex, England, United Kingdom, CM20 1QX
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom, GL1 3NN
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom, HU8 9HE
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, United Kingdom, N18 1QX
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
UCL Cancer Institute
London, England, United Kingdom, WC1E 6DD
Hammersmith Hospital
London, England, United Kingdom, W12 OHS
Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom, PO3 6AD
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S10 2SJ
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Sponsors and Collaborators
University College, London
Eli Lilly and Company
Investigators
Study Chair: John A. Bridgewater University College London (UCL) Cancer Institute
  More Information

Additional Information:
Publications:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00262769     History of Changes
Other Study ID Numbers: CDR0000455013, CRUK-ABC-02, EU-205103, ISRCTN82956140, EUDRACT-2004-004882-14, CTA-21266/0005/001
Study First Received: December 6, 2005
Last Updated: July 16, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
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

Additional relevant MeSH terms:
Bile Duct Neoplasms
Cholangiocarcinoma
Gallbladder Neoplasms
Adenocarcinoma
Bile Duct Diseases
Biliary Tract Diseases
Biliary Tract Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Gallbladder Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014