Back to resultsStudy of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Primary Purpose
Biliary Cancer, Cholangiocarcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine, Irinotecan, Panitumumab
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Cancer focused on measuring Biliary Cancer, Cholangiocarcinoma, Panitumumab
Eligibility Criteria
Inclusion Criteria:
- histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract
- measurable disease
- available tumor tissue for investigational immunohistochemical evaluations
- ECOG PS 0-2
- No prior chemotherapy, biologic therapy or radiation therapy
- Age Eighteen and older
- Lab values per protocol
Exclusion Criteria:
- Life expectancy less than three months
- Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment
- Prior therapy, which affects or targets the EGF pathway
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- Recovery from major surgery within three weeks of the start of study treatment
Sites / Locations
- Abramson Cancer Center at University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemotherapy
Arm Description
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Outcomes
Primary Outcome Measures
Progression Free Survival Rate at Five Months
Secondary Outcome Measures
Response Rate From Combination Chemotherapy
Full Information
NCT ID
NCT00948935
First Posted
May 15, 2009
Last Updated
March 9, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00948935
Brief Title
Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Official Title
Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2009 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 26, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Cancer, Cholangiocarcinoma
Keywords
Biliary Cancer, Cholangiocarcinoma, Panitumumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Irinotecan, Panitumumab
Intervention Description
Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Primary Outcome Measure Information:
Title
Progression Free Survival Rate at Five Months
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Response Rate From Combination Chemotherapy
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract
measurable disease
available tumor tissue for investigational immunohistochemical evaluations
ECOG PS 0-2
No prior chemotherapy, biologic therapy or radiation therapy
Age Eighteen and older
Lab values per protocol
Exclusion Criteria:
Life expectancy less than three months
Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment
Prior therapy, which affects or targets the EGF pathway
Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
Recovery from major surgery within three weeks of the start of study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Giantonia, MD
Organizational Affiliation
Abramson CC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center at University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24146220
Citation
Sohal DP, Mykulowycz K, Uehara T, Teitelbaum UR, Damjanov N, Giantonio BJ, Carberry M, Wissel P, Jacobs-Small M, O'Dwyer PJ, Sepulveda A, Sun W. A phase II trial of gemcitabine, irinotecan and panitumumab in advanced cholangiocarcinoma. Ann Oncol. 2013 Dec;24(12):3061-5. doi: 10.1093/annonc/mdt416. Epub 2013 Oct 20.
Results Reference
derived
Learn more about this trial
Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
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