Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Biliary Cancer, Cholangiocarcinoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival rate at five months

Outcome Time Frame:

Outcome will be measured five months after last evaluable patient is entered on study.

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UPCC 06208

NCT ID:

NCT00948935

Start Date:

April 2009

Completion Date:

June 2013

Related Keywords:

  • Biliary Cancer
  • Cholangiocarcinoma
  • Biliary Cancer
  • Cholangiocarcinoma
  • Panitumumab
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Cholangiocarcinoma
  • Biliary Tract Neoplasms

Name

Location

Abramson Cancer Center at University of PennsylvaniaPhiladelphia, Pennsylvania  19104