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NCT00262769 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2012-07-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Gemcitabine alone
    intervention Names
    1. Drug: gemcitabine hydrochloride
    label
    A - Gemcitabine
    type
    EXPERIMENTAL
  2. description
    Gemcitabine and Cisplatin
    intervention Names
    1. Drug: cisplatin
    2. Drug: gemcitabine hydrochloride
    label
    B - Gemcitabine and Cisplatin
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. B - Gemcitabine and Cisplatin
    description
    25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins
    name
    cisplatin
    other Names
    1. CDDP
    2. cis-diamminedichloroplatinum(II)
    3. cisplatinum
    type
    DRUG
  2. arm Group Labels
    1. A - Gemcitabine
    2. B - Gemcitabine and Cisplatin
    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.
    name
    gemcitabine hydrochloride
    other Names
    1. Gemzar
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
324
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    From date of randomisation till date of death or last date of follow-up (up to 5 years)
    measure
    Overall Survival
    time Frame
    From date of randomisation till date of death or last date of follow-up (up to 5 years)
secondary Outcomes
  1. description
    From date of randomisation till date of death or last date of follow-up (up to 5 years)
    measure
    Progression-free survival
    time Frame
    From date of randomisation till date of death or last date of follow-up (up to 5 years)
  2. description
    Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically
    measure
    Quality of life
    time Frame
    Before and 12 weeks after completion of treatment
  3. 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.
    measure
    Toxicity
    time Frame
    During treatment and follow-up
Full 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.
Source references
references
  1. 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.
    pmid
    20375404
    type
    RESULT
  2. citation
    Lamarca A, Ross P, Wasan HS, Hubner RA, McNamara MG, Lopes A, Palmer DH, Valle JW, Bridgewater J. Advanced extrahepatic cholangiocarcinoma and gallbladder cancer: Post-hoc analysis of the ABC-01, -02 and -03 clinical trials. JHEP Rep. 2026 Jul;8(7):101833. doi: 10.1016/j.jhepr.2026.101833. Epub 2026 Mar 24.
    pmid
    41887529
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        <p id="_549" tabindex="-1">Evidence (chemotherapy):</p> <div class="pdq-content-list"><ol id="_550"><li>The phase III <a href="/clinicaltrials/NCT00262769">ABC-02</a> study (NCT00262769) randomly assigned 410 patients with unresectable, recurrent, or metastatic biliary tract carcinoma to receive either cisplatin
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        "-1">Evidence (chemotherapy):</p> <div class="pdq-content-list"><ol id="_550"><li>The phase III <a href="/clinicaltrials/NCT00262769">ABC-02</a> study (NCT00262769) randomly assigned 410 patients with unresectable, recurrent, or metastatic biliary tract carcinoma to receive either cisplatin plus gemcitabine or gemcitabine
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      source title
      Bile Duct Cancer (Cholangiocarcinoma) Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: March 28, 2025
        datetime
        2025-03-28T12:00:00Z
        display
        March 28, 2025

    Preserved source evidence · Not medical advice