Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with locally advanced cholangiocarcinoma.
| Condition | Intervention |
|---|---|
|
Cholangiocarcinoma Liver Neoplasms |
Drug: floxuridine, dexamethasone Drug: floxuridine, dexamethasone, gemcitabine hydrochloride Drug: floxuridine, dexamethasone, gemcitabine hydrochloride, oxaliplatin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma |
- Toxicity of HAI alone or in combination with systemic oxaliplatin and/or gemcitabine [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Document the frequency of grades 3-5 non-hematologic toxicities (dose-limiting toxicities) associated with the treatment regimen by patient and by type of toxicity for each cohort.
- Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]Describe median time to progression with a 95% confidence interval for each cohort.
- Response rates [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Describe the overall response rate and the response rate within each cohort with 95% confidence intervals.
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Describe median overall survival with a 95% confidence interval and estimate the overall survival rate at 12 and 24 months with 95% confidence intervals.
- Number and grade of adverse events post HAI treatment [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]Determine safety, tolerability and toxicities based on the number and grade of adverse events associated with this regimen.
- Imaging biomarkers of tumor response [ Time Frame: 13 months ] [ Designated as safety issue: No ]Using magnetic resonance diffusion-weighted imaging (DW-MRI) and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) before and early during the course of treatment with HAI therapy, validate imaging biomarkers of tumor response
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort A (HAI)
Patients receive FUDR and dexamethasone via continuous HAI for 14 days of a 28-day treatment cycle.
|
Drug: floxuridine, dexamethasone
floxuridine Given HAI; 0.16mg/kg/day on Days 1-14 of each cycle dexamethasone, Given HAI; 20mg Other Names:
|
|
Experimental: Cohort B (HAI + gemcitabine)
Patients receive FUDR and dexamethasone as in Cohort A. Patients also receive gemcitabine
|
Drug: floxuridine, dexamethasone, gemcitabine hydrochloride
floxuridine Given HAI; 0.12mg/kg/day on Days 1-14 of each cycle dexamethasone Given HAI; 20 mg on Days 1-14 of each cycle gemcitabine hydrochloride Given IV; 1000 mg/m^2 on Days 1, 8 and 15 of each cycle Other Names:
|
|
Experimental: Cohort C (HAI + gemcitabine + oxaliplatin)
Patients receive FUDR and dexamethasone as in Cohort A. Patients also receive gemcitabine and oxaliplatin
|
Drug: floxuridine, dexamethasone, gemcitabine hydrochloride, oxaliplatin
floxuridine Given HAI; 0.12mg/kg/day on Days 1-14 of each cycle dexamethasone Given HAI; 20mg on Days 1-14 of each cycle gemcitabine hydrochloride Given IV; 800 mg/m^2 on Days 1 and 15 of each cycle oxaliplatin Given IV; 85 mg/m^2 on Days 1 and 15 of each cycle Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must have histologically or cytologically confirmed intrahepatic or hilar cholangiocarcinoma with minimal extrahepatic disease
- Patient must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan/MRI
- Patient must have disease that is unresectable or borderline resectable with < 70% liver involvement by cancer
- Patient must be > 18 years old.
- Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%)
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 75,000/mcL
- Total bilirubin =< 2 mg/dL
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 5 X institutional upper limit of normal
- Creatinine within normal institutional limits
- Patient must be able to understand and willing to sign a written informed consent document
Exclusion Criteria:
- Patients must not have had prior treatment with FUDR
- Patient must not be receiving any other investigational agents
- Patient must not have a diagnosis of Gilbert's disease
- Patient must not have a diagnosis of hepatic encephalopathy
- Patient must not have had prior external beam radiation to the liver
- Patient must not have a diagnosis of sclerosing cholangitis
- Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patient must not be pregnant or breastfeeding
Contacts and Locations| Contact: William Chapman, M.D. | 314-362-7792 | chapmanw@wustl.edu |
| Contact: Laura Daigh, BA | 314-362-8547 | daighl@wudosis.wustl.edu |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63122 | |
| Contact: William Chapman, M.D. 314-362-7992 chapmanw@wustl.edu | |
| Contact: Laura Daigh, BA 314-362-8547 daighl@wudosis.wustl.edu | |
| Sub-Investigator: Benjamin Tan, M.D. | |
| Sub-Investigator: Maria Doyle, M.D. | |
| Sub-Investigator: William Hawkins, M.D. | |
| Sub-Investigator: David Linehan, M.D. | |
| Sub-Investigator: A. Craig Lockhart, M.D. | |
| Sub-Investigator: Jeffrey Lowell, M.D. | |
| Sub-Investigator: Joel Picus, M.D. | |
| Sub-Investigator: Timothy Pluard, M.D. | |
| Sub-Investigator: Steven Sorscher, M.D. | |
| Sub-Investigator: Steven Strasberg, M.D. | |
| Sub-Investigator: Rama Suresh, M.D. | |
| Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D. | |
| Sub-Investigator: Kathryn J. Fowler, M.D. | |
More Information
Additional Information:
Publications:
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01525069 History of Changes |
| Other Study ID Numbers: | 201111068 |
| Study First Received: | January 25, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms Liver Neoplasms Cholangiocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Gemcitabine |
Oxaliplatin Floxuridine BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013