Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948935
First received: May 15, 2009
Last updated: February 6, 2013
Last verified: December 2011
  Purpose

This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.


Condition Intervention Phase
Biliary Cancer
Cholangiocarcinoma
Drug: Gemcitabine, Irinotecan, Panitumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Progression free survival rate at five months [ Time Frame: Outcome will be measured five months after last evaluable patient is entered on study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate from combination chemotherapy [ Time Frame: Outcome will be measured five months after last evaluable patient is entered on study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: April 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy
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.
Drug: Gemcitabine, Irinotecan, Panitumumab
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948935

Locations
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948935     History of Changes
Other Study ID Numbers: UPCC 06208
Study First Received: May 15, 2009
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Biliary Cancer
Cholangiocarcinoma
Panitumumab

Additional relevant MeSH terms:
Adenocarcinoma
Cholangiocarcinoma
Biliary Tract Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Irinotecan
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on April 21, 2014