Completed PHASE2 INTERVENTIONAL 1-arm NCT00356889

Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors

A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors

Sponsor: National Cancer Institute (NCI)

Conditions Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma of the Gallbladder Gastrointestinal Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer

Interventions bevacizumab erlotinib hydrochloride

Updated 7 times since 2017 Last updated: May 12, 2014 Started: May 31, 2006 Primary completion: Oct 31, 2008 Completion: Jun 30, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Cholangiocarcinoma of the Extrahepatic Bile Duct and Cholangiocarcinoma of the Gallbladder and is currently completed. National Cancer Institute (NCI) leads this study, which shows 7 recorded versions since 2006 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. Evaluate the objective response rate in patients with metastatic or unresectable cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride. SECONDARY OBJECTIVES: I. Evaluate time to progression in these patients. II. Evaluate overall and progression-free survival of these patients. III. Evaluate the adverse events associated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of study therapy, patients are followed periodically for up to 3 years.

PRIMARY OBJECTIVES:

I. Evaluate the objective response rate in patients with metastatic or unresectable cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride.

SECONDARY OBJECTIVES:

I. Evaluate time to progression in these patients.

II. Evaluate overall and progression-free survival of these patients.

III. Evaluate the adverse events associated with this regimen. OUTLINE: This is an open-label, multicenter study.

Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed periodically for up to 3 years.

Status Flow

Change History

7 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE2
Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

May 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Rochester, United States