ABC06: A trial of Active Symptom Control alone or with OxMdG chemotherapy for patients with advanced biliary tract cancer previously treated with cisplatin/ gemcitabine chemotherapy.
- Conditions
- Biliary tract cancerTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 16.0Level: LLTClassification code 10025734Term: Malignant neoplasm of biliary tract, part unspecifiedSystem Organ Class: 100000004864
- Registration Number
- EUCTR2013-001812-30-GB
- Lead Sponsor
- The Christie NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 162
1. Histologically / cytologically verified, non-resectable or recurrent / metastatic cholangiocarcinoma, gallbladder or ampullary carcinoma.
2. Patients must have failed no more than one prior course of chemotherapy (gemcitabine and cisplatin) with clear evidence of disease progression.
3. ECOG performance status 0-1.
4. Age =18 years and life expectancy >3 months.
5. Adequate renal function:
serum urea and serum creatinine < 1.5 times upper limit of normal (ULN)
creatinine clearance >= 30ml/min
6. Adequate haematological function: Hb * 100g/l, WBC * 3.0 x 10**9/L, ANC * 1.5 x 10**9/L, platelet count * 75 x 10**9/l.
7. Adequate liver function: total bilirubin < 60 umol/L and ALT, AST & alkaline phosphatase <= 5 x ULN.
8. Adequate biliary drainage, with no evidence of ongoing infection (patients on maintenance antibiotics are eligible when acute sepsis has resolved).
9. Women of child bearing age must have a negative pregnancy test prior to study entry and be using an adequate contraception method. This must be continued for 3 months after completion of chemotherapy, unless child bearing potential has been terminated by surgery/radical radiotherapy
10. 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
11. Patients must have given written informed consent
12. Patients must be randomised within 4 weeks of the diagnosis of radiological progression; and patients allocated chemotherapy must start treatment within 6 weeks of diagnosis of disease progression
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 97
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65
1. Incomplete recovery from previous therapy or unresolved biliary tree obstruction (includes ongoing neuropathy of grade >1 from cisplatin)
2. 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
3. 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
4. Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
5. Any other serious uncontrolled medical conditions
6. Clinical evidence of metastatic disease to brain
7. Any pregnant or lactating woman
8. Clinically significant cardiovascular disease. [i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension].
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method