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

Abramson Cancer Center at Penn Medicine

Status and phase: Completed; Phase 2

Conditions: Biliary Cancer; Cholangiocarcinoma

Treatments: Drug: Gemcitabine, Irinotecan, Panitumumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00948935

UPCC 06208

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Chemotherapy

Experimental group

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.

Treatment:

Drug: Gemcitabine, Irinotecan, Panitumumab