Olaparib for Biliary Tract Cancer
This study is evaluating whether a drug may help treat cancer.
See full descriptionAbout the trial for Biliary Tract Cancer
Treatment Groups
This trial involves 2 different treatments. Olaparib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Side Effect Profile for HRRm^
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Biliary Tract Cancer or one of the other 19 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Olaparib will improve 1 primary outcome and 4 secondary outcomes in patients with Biliary Tract Cancer. Measurement will happen over the course of Up to 24 weeks after registration.
Patient Q & A Section
What are the signs of biliary tract cancer?
The main signs of biliary tract cancer are jaundice, abdominal pain and weight loss. Jaundice typically appears over 2 weeks and is associated with fever. Stricture, gallstones and/ or lump may be visible as the tumour progresses. There is evidence of hepatocellular cancer in up to one third of patients which is associated with liver dysfunction and/ or decreased appetite.
What causes biliary tract cancer?
Chronic inflammation in the biliary tree is strongly associated with the development of hepatobiliary cancers. The role of bile acids may be particularly important in the development of carcinoma of the biliary tract in patients with primary sclerosing cholangitis for whom choledochoscopy is performed.
Can biliary tract cancer be cured?
Many patients and caregivers would appreciate the benefit of this study. Although it would appear that more patients would be eligible in the future, our main aim is to determine whether patients with this disease do in fact have longer survival rates once the disease is successfully treated. We hope that our findings will convince patients and their families that their life span can be prolongable by choosing to receive active treatment, even if they are not in a location that has an existing biliary tract cancer treatment centre. It is our hope that further studies that compare current and experimental treatment options for this disease will lead to improved treatment modalities and patient survival outcomes.
What is biliary tract cancer?
Biliary tract cancer is a disease that has been steadily increasing in incidence. In the developed world, it may become an important cause of death in the future. We suggest a definition for an early diagnosis of biliary tract cancer and an establishment of an accurate and precise diagnostic protocol for it.
How many people get biliary tract cancer a year in the United States?
Biliary tract cancer is relatively common (10,000 cases per year) in the US, representing 3-5% of all male liver cancer cases. In patients with resectable pancreatobiliary malignancies, a multimodality approach to chemoradiation resulted in an overall survival benefit similar to that demonstrated by the National Surgical Adjuvant Breast and Bowel Project (NSABP).
What are common treatments for biliary tract cancer?
Most common treatment options for biliary tract cancers include surgery, chemotherapy, radiation therapy and targeted therapy. Because of the limited data that exist on outcomes and cost-benefit analyses for all of these modalities for treating this disease, the use of specific surgical, radiation, and targeted therapies remain a contentious subject, and future studies will be required to adequately evaluate efficacy and cost-effectiveness for the management of biliary tract cancers.
Who should consider clinical trials for biliary tract cancer?
Although current treatment, such as a surgical resection or a transarterial chemoembolization, could be a palliative therapy, the median survival time is about 2 years. Because of the lack of sufficient evidence for its efficacy, clinical trials could provide more effective treatment.
Does biliary tract cancer run in families?
Findings from a recent study provides evidence that more than 80% (13 out of 16) of the families had a history of a second biliary tract cancer. If the occurrence of biliary tumor is a part of the autosomal dominant pattern we should consider a genetic study in families harboring biliary malignancies or a more complete gene analysis in those with only a family history of the disease.
How does olaparib work?
Olaparib inhibits progression to BCLC stage 1 HCC by blocking the ability of BCLC-C cells to invade blood vessels, which results in decreased tumor proliferation and angiogenesis. Further studies with more patients and longer durations of olaparib therapy are warranted.
What are the latest developments in olaparib for therapeutic use?
Olaparib has progressed smoothly to the point where its use, especially in combination with platinum-based chemotherapy, is now being widely adopted for the treatment of a variety of solid tumors.
Have there been any new discoveries for treating biliary tract cancer?
Until recent years, most of the treatment for patients with biliary cancer had been based on the principles of neoadjuvant treatment, in which preoperative treatment was given to reduce tumor size and staging, followed by surgical removal of the tumor, and finally adjuvant therapies. Today, we have many different adjuvant therapies that can help treat the disease; the main target of each individual therapy is to destroy metastases and shrink the primary tumor.
Does olaparib improve quality of life for those with biliary tract cancer?
In this first phase II, nonrandomised, open-label study, daily treatment with 240/300/400mg oral olaparib was well tolerated, and was associated with an improvement in HR-QoL, a measure of HRQoL, and cancer-related fatigue. Further studies are needed to confirm these findings among a large number of patients in phase III clinical trials.