Overview

Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers

Status:
Completed
Trial end date:
2019-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether fit patients (with ECOG performance score of 0-1) with advanced biliary tract cancer (ABC) benefit from chemotherapy in the second-line setting (after prior therapy with cisplatin and gemcitabine) in terms of overall survival.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborator:
Cancer Research UK
Treatments:
Fluorouracil
Folic Acid
Leucovorin
Levoleucovorin
Oxaliplatin
Criteria
Inclusion Criteria:

- Histologically / cytologically verified, non-resectable or recurrent / metastatic
cholangiocarcinoma, gallbladder or ampullary carcinoma.

- Patients must have failed no more than one prior course of chemotherapy (gemcitabine
and cisplatin) with clear evidence of disease progression.

- ECOG performance status 0-1.

- Age >=18 years and life expectancy >3 months.

- Adequate renal function with serum urea and serum creatinine < 1.5 times upper limit
of normal (ULN) and creatinine clearance >= 30ml/min

- Adequate haematological function: Hb >= 100g/l, WBC >= 3.0 x 10*9/L, ANC >= 2 x
10*9/L, platelet count >= 100 x 10*9/L

- Adequate liver function: total bilirubin < 60 μmol/L and ALP, along with AST and/or
ALT ≤ 5 x ULN

- Adequate biliary drainage, with no evidence of ongoing infection (patients on
maintenance antibiotics are eligible when acute sepsis has resolved).

- 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 4 months
after the study, unless child bearing potential has been terminated by surgery/radical
radiotherapy

- Men must be willing to use an adequate method of contraception during chemotherapy and
until 6 months after chemotherapy

- Patients must have given written informed consent

- Patients must be randomised and those allocated chemotherapy must start treatment
within 6 weeks of diagnosis of disease progression

Exclusion criteria:

- Incomplete recovery from previous therapy or unresolved biliary tree obstruction
(includes ongoing neuropathy of grade >1 from cisplatin)

- 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

- 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

- Any patient with a medical or psychiatric condition that impairs their ability to give
informed consent

- Any other serious uncontrolled medical conditions

- Clinical evidence of metastatic disease to brain

- Any pregnant or lactating woman

- 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].

**Hypertension grading of ≥ 3 is an exclusion criteria (CTCAE v4.03). However,
patients who have controlled hypertension with medication and/or diet may be included
at the investigator's discretion. (This should be noted in the medical history section
of the CRF).

- Patients must not have a history of other malignant diseases within the last 5 years
(other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the
uterine cervix).