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Completed

NCT Number: NCT00948935

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

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

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Key information

Conditions

Biliary Cancer Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine, Irinotecan, Panitumumab

Drug

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 outcomes

  1. Progression Free Survival Rate at Five Months

    Time frame: 5 months

Secondary outcomes

  1. Response Rate From Combination Chemotherapy

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2009
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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