Nanoliposomal Irinotecan for Biliary Tract Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lombardi Comprehensive Cancer Center, Georgetown University, Washington, United States
Biliary Tract Cancer+1 More
Nanoliposomal Irinotecan - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new combination of chemotherapy drugs can improve the survival of patients with advanced biliary tract cancers.

See full description

Eligible Conditions

  • Biliary Tract Cancer
  • Advanced Biliary Tract Cancer(BTC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Biliary Tract Cancer

Study Objectives

This trial is evaluating whether Nanoliposomal Irinotecan will improve 1 primary outcome, 1 secondary outcome, and 2 other outcomes in patients with Biliary Tract Cancer. Measurement will happen over the course of 4 months.

4 months
The efficacy of fluorouracil, leucovorin, and nanoliposomal irinotecan in advanced biliary tract cancers following progression on or intolerance of gemcitabine and platinum chemotherapy.
6 months
Archived tumor tissue using next-generation sequencing (NGS) and immunohistochemistry (IHC) in order to elucidate potential mutational biomarkers predictive of response to fluorouracil, leucovorin, and nanoliposomal irinotecan.
Blood for the analysis of circulating tumor DNA as a surrogate marker of disease burden.
The activity of fluorouracil, leucovorin, and nanoliposomal irinotecan in patients with advanced biliary tract cancers treated following progression on or intolerance of gemcitabine and platinum chemotherapy.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Biliary Tract Cancer

Trial Design

1 Treatment Group

Single Arm
1 of 1
Experimental Treatment

This trial requires 44 total participants across 1 different treatment group

This trial involves a single treatment. Nanoliposomal Irinotecan 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.

Single ArmNanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days. Leucovorin 400 mg/ IV over 30 minutes, every 14 days. Fluorouracil 2,400 mg/m IV over 46 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Leucovorin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Lombardi Comprehensive Cancer Center, Georgetown University - Washington, United States

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
are common despite the use of novel agents and strategies Despite the use of novel agents and strategies, disease progression on or intolerance of gemcitabine- and platinum-based chemotherapy is common. show original
The patient has a measurable disease by RECIST v1.1 criteria. show original
If you have HIV, you may be eligible for this study if you have a stable HAART regimen, no concurrent prophylactic antibiotics or antifungals, and a CD4 count above 250 and undetectable viral load. show original
Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic
The patient's ECOG performance status is 0-1, indicating that they are in good health. show original
You must be at least 18 years old to purchase this product. show original
Adequate bone marrow, hepatic, and renal function
I consent to having my tumor tissue archived, if available, for research purposes show original
No more than one line of chemotherapy is allowed for unresectable or metastatic disease show original

Patient Q&A Section

Can biliary tract cancer be cured?

"Cholangiocarcinoma can be cured if the tumors have been removed completely and the bile ducts are normal or have been resected from the tumor site. Bacteria (i.e., Gram-positive cocci or Gram-negative rods)/eukaryotes (i.e., yeasts or fungi) seem to have a favorable effect versus the tumor cells for survival and regression of cholangiocarcinoma." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of biliary tract cancer?

"Although biliary tract cancer may be associated with hepatic inflammation, the relationship between inflammation and cancer is not well defined. Biliary tract cancer may be attributable to genetic predisposition or environmental factors." - Anonymous Online Contributor

Unverified Answer

What are the signs of biliary tract cancer?

"There are no specific symptoms and signs related to biliary tract cancers, as any change to the biliary tract, such as itch, dyspepsia etc. need to be investigated in patients with no symptoms." - Anonymous Online Contributor

Unverified Answer

What are common treatments for biliary tract cancer?

"Patients with Stage III and Stage IV cholangiocarcinoma may have metastases from the primary tumor or disseminated tumor cells. In select cases, surgery may be curative but it will rarely result in a cure. Treatment for patients with Stage III disease may include concurrent chemotherapy and/or radiation therapy, local chemotherapy (biliary tract occlusion) and/or surgery; these treatments may be curative for patients with Stage IV disease. Patients with a potentially curable recurrence of their disease may benefit from second cytoreductive chemotherapy and, if necessary, additional chemotherapy. New advances in biliary tract cancer treatment are underway, but the treatment options for patients with recurrent disease may be limited." - Anonymous Online Contributor

Unverified Answer

How many people get biliary tract cancer a year in the United States?

"Around 30,000 people will be diagnosed with cholangiocarcinoma. Around 75% of these will be diagnosed with localized disease. Most of these will have resectable disease. The 10 to 15 % survival data from a randomized controlled trial suggest treatment for localized disease should aim at resection; adjuvant treatment is not warranted." - Anonymous Online Contributor

Unverified Answer

What causes biliary tract cancer?

"The vast majority of biliary tract cancer cases arise after cholecystectomy and most patients present with nonfunctioning tumors. A choledochal cyst is the most frequent cause of cancer in benign diseases." - Anonymous Online Contributor

Unverified Answer

What is biliary tract cancer?

"A careful history, physical examination and, when indicated, imaging, can help identify potential problems. When an abnormality is found, a referral to a medical oncologist is appropriate." - Anonymous Online Contributor

Unverified Answer

Does biliary tract cancer run in families?

"Although the prevalence of cancer in BTC families is much higher than in the general population and it is inherited in an autosomal dominant manner, the occurrence of tumors in a BTC family does not seem to follow an Mendelian pattern of inheritance." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nanoliposomal irinotecan for therapeutic use?

"[With Nanoparticle Drug Systems, in situ-forming and responsive nanocapsules of polymers containing an anticancer agent, enabling a local, non-systemic, sustained and efficient administration of a drug for local use.]. A nanoformulation of irinotecan (trade name: CPT 11) is in development at Amgen Pharmaceuticals. This nanoformulation is being evaluated in a Phase I/II study in patients with the tumor type of colorectal cancer that includes metastases. Amgen is also evaluating the effects of this nanoformulation on other tumor types, notably pancreatic and gastric." - Anonymous Online Contributor

Unverified Answer

How serious can biliary tract cancer be?

"The current study concluded that BIC in the elderly is associated with poor prognosis. However, patients with BIC are at risk of postoperative infectious complications when the cancer is resected and the patient recovers from the operation. Therefore, surgeons should be cautious in surgical procedure when the patient suffers from BIC." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nanoliposomal irinotecan?

"A phase I trial involving two dosing regimes of irinotecan exhibited antitumor activity in a small number of patients. Results from a recent paper of this trial will be used to design the phase II trial to investigate the optimal dose/schedule of irinotecan in patients with disease refractory to paclitaxel and other cytotoxic agents or with intolerance to paclitaxel." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for biliary tract cancer?

"Clinicians should consider participation in clinical trials if they would benefit from adjuvant systemic therapy. However, a subgroup of patients, defined by clinical and pathological factors, appears to receive minimal benefit from treatment trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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