Gemcitabine, alone or in combination with cisplatin, in patients with advanced or metastatic cholangiocarcinomas and other biliary tract tumours

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 86

Inclusion Criteria

1. Histologically or cytologically verified, non-resectable or recurrent/metastatic cholangiocarcinoma (intra- or extra-hepatic), gallbladder or ampullary carcinoma
2. Measurable, non-measurable or evaluable disease on computed tompgraphy (CT) or magnetic resonance (MR) scanning. Radiological assessments must be done within 4 weeks of starting chemotherapy.
3. Karnofsky performance status greater or equal to 60
4. Age greater than or equal to 18 years, either sex
5. Life expectancy greater than 3 months
6. Adequate renal function with serum urea and serum creatinine less than 1.5 times upper limit of normal (ULN) and glomerular filtration rate greater or equal to 60 ml/min as measured by creatinine clearance or EDTA or calculated by using the Cockroft formula
7. Adequate haematological function:
7.1. Haemoglobin greater or equal to 10 g/dl
7.2. White blood cell count (WBC) greater or equal to 3.0 x 10^9/L
7.3. Absolute neutrophil count (ANC) greater or equal to 1.5 x 10^9/L
7.4. Platelet count greater or equal to 100,000/mm^3
8. Adequate liver function:
8.1. Total bilirubin less than 30 mmol/L
8.2. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase less than or equal to 3 x ULN (unless liver metastases are present, when they can be less than or equal to 5 x ULN)
9. Adequate biliary drainage, with no evidence of ongoing infection
10. Women of child bearing age MUST have a negative pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 3 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy
11. Previous radiotherapy (or chemo-radiotherapy) is allowed, as long as the measurable disease to be evaluated in this study does not fall within the previous radiotherapy treatment field
12. Prior photodynamic therapy is allowed, provided there has been clear radiological evidence of disease progression
13. Patients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix
14. Patients must have given written informed consent

Exclusion Criteria

1. Incomplete recovery from previous surgery or unresolved biliary tree obstruction
2. Any previous chemotherapy (with the exception of low-dose chemotherapy used as a radiosensitiser during combined modality chemo-radiotherapy)
3. Previous investigational agent in the last 12 weeks
4. Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial
5. Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial
6. Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
7. Any other serious uncontrolled medical conditions
8. Clinical evidence of metastatic disease to brain
9. Any pregnant or lactating woman

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy in terms of 6-month progression-free rate for both treatment arms

Secondary Outcome Measures

Name	Time	Method
<br> 1. Overall survival<br> 2. Response rate, evaluated after 12 and 24 weeks of treatment via CT, according to WHO guidelines<br> 3. Toxicity assessment (adverse events [AEs] graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] criteria)<br>

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