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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00262769
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : July 17, 2012
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2005
Actual Primary Completion Date : August 2008


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of randomisation till date of death or last date of follow-up (up to 5 years) ]
    From date of randomisation till date of death or last date of follow-up (up to 5 years)


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: From date of randomisation till date of death or last date of follow-up (up to 5 years) ]
    From date of randomisation till date of death or last date of follow-up (up to 5 years)

  2. Quality of life [ Time Frame: Before and 12 weeks after completion of treatment ]
    Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically

  3. Toxicity [ Time Frame: During treatment and follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262769


Locations
Show Show 25 study locations
Sponsors and Collaborators
University College, London
Eli Lilly and Company
Investigators
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Study Chair: John A. Bridgewater University College London (UCL) Cancer Institute
Publications of Results:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00262769    
Other Study ID Numbers: CDR0000455013
CRUK-ABC-02
EU-205103
ISRCTN82956140
EUDRACT-2004-004882-14
CTA-21266/0005/001
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
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:
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Cholangiocarcinoma
Gallbladder Neoplasms
Bile Duct Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs