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Sorafenib Tosylate and Erloti...

Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma

Last Updated: 2015-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-09-30

Brief Summary

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This phase II trial is studying how well giving sorafenib tosylate together with erlotinib hydrochloride works in treating patients with locally advanced, unresectable, or metastatic gallbladder cancer or cholangiocarcinoma. Sorafenib tosylate and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

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Detailed Description

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OBJECTIVES:

I. To assess the progression-free survival in patients with unresectable or metastatic gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib (sorafenib tosylate) and erlotinib (erlotinib hydrochloride).

II. To assess the overall survival in patients with unresectable or metastatic gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib and erlotinib.

III. To assess the objective response rate. IV. To assess the frequency and severity of toxicities. V. To collect specimens for banking for future research.

OUTLINE: This is a multicenter study.

Patients receive sorafenib tosylate orally (PO) twice daily and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 6 months for 3 years.

Conditions

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Extrahepatic Bile Duct Adenocarcinoma Gallbladder Adenocarcinoma Gallbladder Adenocarcinoma With Squamous Metaplasia Hilar Cholangiocarcinoma Recurrent Extrahepatic Bile Duct Carcinoma Recurrent Gallbladder Carcinoma Undifferentiated Gallbladder Carcinoma Unresectable Extrahepatic Bile Duct Carcinoma Unresectable Gallbladder Carcinoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (sorafenib tosylate and erlotinib hydrochloride)

Patients receive sorafenib tosylate PO twice daily and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Erlotinib Hydrochloride

Intervention Type DRUG

Given PO

Sorafenib Tosylate

Intervention Type DRUG

Given PO

Interventions

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Erlotinib Hydrochloride

Given PO

Intervention Type DRUG

Sorafenib Tosylate

Given PO

Intervention Type DRUG

Other Intervention Names

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Cp-358,774 OSI-774 Tarceva BAY 43-9006 Tosylate BAY 54-9085 Nexavar sorafenib

Eligibility Criteria

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Inclusion Criteria

* Cytologically or pathologically confirmed gallbladder carcinoma or cholangiocarcinoma

* No ampullary carcinoma
* Locally advanced unresectable or distant metastatic disease
* Measurable disease
* Patients with biliary obstruction must have decompression of the biliary tree by ERCP and stenting or percutaneous drainage
* No prior systemic treatment for metastatic or unresectable locally advanced disease
* No known brain metastases
* Zubrod performance status of 0-1
* Leukocyte count ≥ 3,000/mm\^3
* ANC ≥ 1,000/mm\^3
* Platelet count ≥100,000/mm\^3
* Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

* For patient who had decompression of the biliary tree within the past 14 days, stability of the bilirubin level needs to be confirmed with two measurements within 5 to 7 days of each other
* Serum albumin ≥ 2.5 g/dL
* AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)
* Creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Fertile patients must agree to use effective contraception
* No active biliary sepsis
* No bleeding diathesis
* No uncontrolled or clinically significant cardiovascular disease, including any of the following:

* Myocardial infarction within the past 6 months
* Uncontrolled angina within the past 6 months
* NYHA class II-IV congestive heart failure
* Grade 3 cardiac valve dysfunction
* Cardiac arrhythmia not controlled by medication
* History of stroke or transient ischemic attack within the past 6 months
* History of arterial thrombotic event of any type in the past 6 months
* No uncontrolled hypertension, as evidenced by systolic BP ≥ 150 mm Hg or diastolic BP ≥ 100 mm Hg, within the past 28 days
* Must be able to swallow and tolerate oral medications

* No gastrointestinal tract disease or prior abdominal surgery that results in an inability to absorb oral medication
* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free within the past 3 years
* No concurrent grapefruit or its juice
* At least 6 months since 1 adjuvant or neoadjuvant regimen of chemotherapy, hormonal therapy, immunotherapy, radiotherapy (to \< 25% of bone marrow only), or chemoradiotherapy before documented recurrence or metastatic disease
* No prior treatment with any antiangiogenic agent or any EGFR inhibitors for any reason
* Concurrent multiple anti-hypertensive medications allowed
* No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other therapy, including herbal or alternative medications for treatment of cancer

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony El-Khoueiry

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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The University of Arizona Medical Center-University Campus

Tucson, Arizona, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Fremont - Rideout Cancer Center

Marysville, California, United States

Site Status

Sutter Cancer Research Consortium

Novato, California, United States

Site Status

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Valley Medical Oncology Consultants

Pleasanton, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

UF Cancer Center at Orlando Health

Orlando, Florida, United States

Site Status

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status