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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01093222
First received: March 24, 2010
Last updated: April 29, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Extrahepatic Bile Duct
Adenocarcinoma of the Gallbladder
Adenocarcinoma With Squamous Metaplasia of the Gallbladder
Anaplastic Carcinoma of the Gallbladder
Cholangiocarcinoma of the Extrahepatic Bile Duct
Cholangiocarcinoma of the Gallbladder
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Drug: sorafenib tosylate
Drug: erlotinib hydrochloride
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

  • Objective Response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions and no disease related symptoms. Partial response (PR) is a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.

  • Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Only adverse events that are possibly, probably or definitely related to study drug are reported.


Enrollment: 40
Study Start Date: April 2010
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: sorafenib tosylate
Given PO
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: erlotinib hydrochloride
Given PO
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093222

  Show 140 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Anthony El-Khoueiry Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01093222     History of Changes
Other Study ID Numbers: NCI-2011-02027, NCI-2011-02027, SWOG-S0941, CDR0000668246, S0941, S0941, U10CA032102
Study First Received: March 24, 2010
Results First Received: November 1, 2013
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Metaplasia
Gallbladder Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases
Erlotinib
Sorafenib
Niacinamide
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 18, 2014