Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT00262769
Status:
COMPLETED
Last Update Posted:
2012-07-17
First Post:
2005-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001650', 'term': 'Bile Duct Neoplasms'}, {'id': 'D005706', 'term': 'Gallbladder Neoplasms'}], 'ancestors': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2005-12-06', 'studyFirstSubmitQcDate': '2005-12-06', 'lastUpdatePostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From date of randomisation till date of death or last date of follow-up (up to 5 years)', 'description': 'From date of randomisation till date of death or last date of follow-up (up to 5 years)'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'From date of randomisation till date of death or last date of follow-up (up to 5 years)', 'description': 'From date of randomisation till date of death or last date of follow-up (up to 5 years)'}, {'measure': 'Quality of life', 'timeFrame': 'Before and 12 weeks after completion of treatment', 'description': 'Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically'}, {'measure': 'Toxicity', 'timeFrame': 'During treatment and follow-up', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'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'], 'conditions': ['Extrahepatic Bile Duct Cancer', 'Gallbladder Cancer']}, 'referencesModule': {'references': [{'pmid': '20375404', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* Compare the progression-free survival of patients treated with these regimens.\n* Compare the toxic effects of these regimens in these patients.\n* Compare quality of life of patients treated with these regimens.\n\nOUTLINE: 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.\n\n* 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.\n* 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.\n\nQuality of life is assessed at baseline, 12 weeks, and after finishing treatment.\n\nAfter completion of study treatment, patients are followed periodically for at least 3 years.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nPROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma\n\n * Intra- or extra-hepatic disease allowed\n* Unresectable locally advanced, recurrent, or metastatic disease\n* No brain metastases\n\nPATIENT CHARACTERISTICS:\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 10 g/dL (transfusion allowed)\n* WBC ≥ 3,000/mm\\^3\n\nHepatic\n\n* AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)\n* Bilirubin ≤ 1.5 times ULN\n* Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)\n* Adequate biliary drainage\n* No unresolved biliary tract obstruction\n\nRenal\n\n* Creatinine \\< 1.5 times ULN\n* Urea \\< 1.5 times ULN\n* Glomerular filtration rate (GFR) ≥ 45 mL/min\n\n * If GFR \\< 60 mL/min, isotope EDTA confirmation of adequate renal function is required\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after study participation\n* No active, uncontrolled infection\n* No other severe or uncontrolled systemic disease\n* 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\n* No psychiatric disorder that would preclude giving informed consent\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* At least 6 months since prior adjuvant chemotherapy\n* No prior gemcitabine hydrochloride\n* No prior cisplatin\n* No prior systemic chemotherapy for locally advanced or metastatic disease except low-dose radiosensitizing chemotherapy in conjunction with radiotherapy\n\nRadiotherapy\n\n* Prior radiotherapy for localized disease allowed provided there is clear evidence of disease progression afterwards\n\nSurgery\n\n* Prior curative surgery allowed provided there is evidence of nonresectable disease relapse requiring systemic chemotherapy\n\nOther\n\n* Recovered from all prior therapies\n* 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\n\n * PDT must have been completed ≥ 4 weeks ago\n* At least 4 weeks since prior investigational agents\n* No other concurrent, curative anticancer therapy'}, 'identificationModule': {'nctId': 'NCT00262769', 'acronym': 'ABC-02', 'briefTitle': 'Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CDR0000455013'}, 'secondaryIdInfos': [{'id': 'CRUK-ABC-02'}, {'id': 'EU-205103'}, {'id': 'ISRCTN82956140'}, {'id': 'EUDRACT-2004-004882-14'}, {'id': 'CTA-21266/0005/001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A - Gemcitabine', 'description': 'Gemcitabine alone', 'interventionNames': ['Drug: gemcitabine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'B - Gemcitabine and Cisplatin', 'description': 'Gemcitabine and Cisplatin', 'interventionNames': ['Drug: cisplatin', 'Drug: gemcitabine hydrochloride']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'otherNames': ['CDDP', 'cis-diamminedichloroplatinum(II)', 'cisplatinum'], 'description': '25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins', 'armGroupLabels': ['B - Gemcitabine and Cisplatin']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'otherNames': ['Gemzar'], '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.', 'armGroupLabels': ['A - Gemcitabine', 'B - Gemcitabine and Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG24 9NA', 'city': 'Basingstoke', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Basingstoke and North Hampshire NHS Foundation Trust', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CA2 7HY', 'city': 'Carlisle', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cumberland Infirmary', 'geoPoint': {'lat': 54.8951, 'lon': -2.9382}}, {'zip': 'GL53 7AN', 'city': 'Cheltenham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Oncology Centre at Cheltenham General Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'DE1 2QY', 'city': 'Derby', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derbyshire Royal Infirmary', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'CM20 1QX', 'city': 'Essex', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Princess Alexandra Hospital'}, {'zip': 'GL1 3NN', 'city': 'Gloucester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'zip': 'HU8 9HE', 'city': 'Hull', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Princess Royal Hospital at Hull and East Yorkshire NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'N18 1QX', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Helen Rollason Cancer Care Centre at North Middlesex Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden - London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 OHS', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1E 6DD', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'UCL Cancer Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WIT 3AA', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University College of London Hospitals', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Maidstone Hospital', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'CH63 4JY', 'city': 'Merseyside', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology'}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre at Mount Vernon Hospital', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'PO3 6AD', 'city': 'Portsmouth Hants', 'state': 'England', 'country': 'United Kingdom', 'facility': "Portsmouth Oncology Centre at Saint Mary's Hospital"}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research Centre at Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital Trust Incorporating Belvoir Park Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'CF14 2TL', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Velindre Cancer Center at Velindre Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'LL 18 5UJ', 'city': 'Rhyl, Denbighshire', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Glan Clwyd Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}], 'overallOfficials': [{'name': 'John A. Bridgewater', 'role': 'STUDY_CHAIR', 'affiliation': 'University College London (UCL) Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}