None listed
Conditions
Brief summary
This study aims to evaluate the safety and efficacy of combining panitumumab with the standard cisplatin and gemcitabine treatment for advanced biliary tract cancer. Who is it for? You may be eligible to join this study if you are 18 years or above and have been diagnosed with biliary tract cancer. You should have locally advanced or metastatic disease that is not suitable for removal by surgery OR disease which has come back after previous surgical treatment or radiotherapy. It has been shown that in other cancer types, panitumumab may be less likely to have an effect if the cancer cells have any mutation detected in a particular gene. That gene is known as KRAS. As part of screening for this study, you will be asked to consent to a test to find out whether your cancer cells have a KRAS mutation. If you consent, cells taken from a previous diagnostic procedure will be sent to a central lab for the KRAS test. Only patients with cancer that does not have any mutation in the KRAS gene can participate in this study. Trial details The patient population that may participate in this trial would routinely be treated with a combination of the chemotherapy drugs gemcitabine and cisplatin. Participants in this study will additionally receive panitumumab; so that the outcomes associated with treatment using the 3 drugs together can be evaluated. Participants will be monitored closely for side effects (toxicity) and for tumour response to treatment. Treatment will continue until disease progression, unacceptable toxicity, investigator discretion or patient request to cease. Once off study treatment, participants will be followed up for 30 days, then every 12 weeks until disease progression or commencement of new treatment, then according to best practice until death. Data from this trial can inform us about how safe and tolerable the treatment is, and we can make some comparisons to other trials of chemotherapy alone for this disease. If positive, this study may lead to improved treatment for patients with biliary tract cancer. If negative, it will still give information regarding the biology of the disease, including the incidence of KRAS mutation in this tumour type.
Interventions
Patients recruited to the study will receive the following:
Panitumumab 9mg/kg IV, Day 1 of each cycle
Cisplatin 25mg/m2 IV, Day 1 and 8
Gemcitabine 1000mg/m2 IV, Day 1 and 8
Treatment is ongoing until disease progression, unacceptable toxicity, investigator discretion or patient request to cease.
Once off study treatment, patients will be followed-up 30 days after the last study drug administration, then every 12 weeks until disease progression (if patient had come off treatment for reasons
Patients recruited to the study will receive the following: Panitumumab 9mg/kg IV, Day 1 of each cycle Cisplatin 25mg/m2 IV, Day 1 and 8 Gemcitabine 1000mg/m2 IV, Day 1 and 8 Treatment is ongoing until disease progression, unacceptable toxicity, investigator discretion or patient request to cease. Once off study treatment, patients will be followed-up 30 days after the last study drug administration, then every 12 weeks until disease progression (if patient had come off treatment for reasons other than progression) or commences new treatment.
Sponsors
Australasian Gastrointestinal Trials Group (AGITG)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Histologic or cytologic diagnosis of adenocarcinoma of the gallbladder or intra/extrahepatic bile ducts with locally advanced or metastatic disease (at study entry) that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy; 2.K-RAS wild-type oncogene; 3.Uni-dimensional measurable disease as assessed by CT scan (RECIST v1.1 criteria). 4.Patients must have received no prior chemotherapy or biological therapy for advanced disease; 5.Prior radiotherapy must be completed at least 4 weeks before study enrolment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrolment; 6.WHO performance status 0, 1 or 2; 7.Estimated life expectancy of at least 12 weeks; 8.Patient compliance and geographic proximity that allows adequate follow-up; 9.Adequate organ function including the following: a.Adequate bone marrow reserve: absolute neutrophil count (ANC) of greater than or equal to 1.5 x109/L, platelet count of greater than or equal to 100 x109/L, and haemoglobin of greater than or equal to 9 g/dL. b.Hepatic: AST and ALT less than 5 x upper limit of normal (ULN); bilirubin less than 2 x ULN; in patients with obstructive jaundice and bilirubin greater than or equal 2 x ULN, internal or external biliary drainage should be performed before enrollment. Patients should be enrolled only if bilirubin declines to greater than or equal 2 x ULN. c.Renal: creatinine less than 1. 5 x ULN and calculated creatinine clearance greater than or equal to 50 mL/min, calculated according to the Cockcroft formula. 10.Signed informed consent from patient or legal representative. 11.Patients available to complete study requirements (visits, tests, evaluations and follow-up procedures) in a timely manner. 12.Male and female patients with reproductive potential must use a reliable contraceptive method if appropriate (eg, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the study. Females with childbearing potential must have a negative urine pregnancy test within 7 days prior to study enrolment.
Exclusion criteria
1.Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or comply with the study protocol; 2.Heart failure, angina pectoris or arrhythmia that are poorly controlled in spite of medication or acute myocardial infarction within 6 months preceding study enrollment; 3.Active infection that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy, especially uncontrolled biliary tract infections; 4.Poorly controlled diabetes mellitus; 5.Interstitial lung disease 6.Any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator; 7.Pregnancy or breast feeding or unwilling / unable to practice adequate contraception 8.Second primary malignancy (except in situ carcinoma of the cervix or adequately treated non-melanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence) 9.Pregnancy or breast feeding or unwilling / unable to practice adequate contraception. 10.Documented brain metastasis.
Outcome results
None listed