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Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or Cholangiocarcinoma
This study is ongoing, but not recruiting participants.
First Received: October 12, 2005   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00238212
  Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Drug: sorafenib tosylate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of BAY 43-9006 (NSC #724772) as Single Agent in Unresectable or Metastatic Gallbladder Carcinoma and Cholangiocarcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response probability (confirmed complete and confirmed partial responses) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2005
Detailed Description:

OBJECTIVES:

  • Determine the objective response (complete and partial) in patients with unresectable or metastatic gallbladder carcinoma or cholangiocarcinoma treated with sorafenib.
  • Determine the overall and progression-free survival of patients treated with this drug.
  • Determine time to treatment failure in patients treated with this drug.
  • Determine the quantitative and qualitative toxic effects of this drug in these patients.
  • Determine, preliminarily, the prognostic and predictive molecular markers of clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within approximately 8.3 - 25 months.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed cholangiocarcinoma or gallbladder carcinoma

    • Histologic confirmation of adenocarcinoma of a metastatic site with clinical documentation of gallbladder or bile duct involvement allowed provided there is no evidence of another primary

      • Clinical and/or radiographical findings consistent with cholangiocarcinoma plus histologic findings from metastatic site allowed if clinical documentation of gallbladder or bile duct involvement is not possible due to removal of the organ
  • Patients must have 1 of the following histologic types:

    • Papillary carcinoma
    • Adenocarcinoma
    • Intestinal type
    • Clear cell adenocarcinoma
    • Mucinous adenocarcinoma
    • Signet ring cell carcinoma
    • Squamous cell carcinoma
    • Adenosquamous carcinoma
    • Small cell carcinoma
    • Undifferentiated carcinoma
    • Adenocarcinoma not otherwise specified
    • Carcinoma not otherwise specified
  • Locally advanced or distant metastatic disease not surgically curable
  • Measurable disease
  • Decompression of the biliary tree by ERCP and stenting or percutaneous drainage required if any biliary obstruction
  • No carcinoid tumors or sarcomas
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,000/mm^3
  • No evidence of bleeding diathesis

Hepatic

  • Bilirubin ≤ 3 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
  • PT, INR, and PTT normal

Renal

  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • None of the following significant uncontrolled cardiac diseases:

    • Congestive heart failure
    • Symptomatic coronary artery disease
    • Cardiac arrhythmias
  • No myocardial infarction within the past 12 months
  • No uncontrolled hypertension

Gastrointestinal

  • Able to swallow and/or receive enteral medications by gastrostomy feeding tube
  • No malabsorption syndrome
  • No intractable nausea or vomiting

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV-positive patients allowed provided CD4 count > 500/mm^3 AND patient has no active opportunistic infection and are not receiving combination antiretroviral therapy
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior sorafenib or any vascular endothelial growth factor receptor or MAPK pathway inhibitor
  • Prior neoadjuvant or adjuvant immunotherapy allowed provided it was completed ≥ 12 months before documented disease recurrence or metastasis
  • No concurrent immunotherapy

Chemotherapy

  • Prior neoadjuvant or adjuvant chemotherapy allowed provided it was completed ≥ 12 months before documented disease recurrence or metastasis
  • No concurrent chemotherapy

Endocrine therapy

  • Prior neoadjuvant or adjuvant hormonal therapy allowed provided it was completed ≥ 12 months before documented disease recurrence or metastasis
  • No concurrent hormonal therapy

Radiotherapy

  • At least 28 days since prior radiotherapy and recovered
  • Prior radiotherapy to < 25% of bone marrow or metastatic sites allowed provided there are other not treated measurable lesions AND therapy was completed ≥ 12 months before documented disease recurrence or metastasis
  • No concurrent radiotherapy except palliative radiotherapy to metastatic non-target lesions

Surgery

  • At least 14 days since prior surgery and recovered

Other

  • No prior therapy for unresectable or metastatic disease
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, and phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
  • No other concurrent therapy for cancer
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic anticoagulation of venous or arterial access devices allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238212

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Anthony B. El-Khoueiry, MD USC/Norris Comprehensive Cancer Center
Investigator: Heinz-Josef Lenz, MD USC/Norris Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
El-Khoueiry AB, Rankin C, Lenz HJ, et al.: SWOG 0514: a phase II study of sorafenib (BAY 43-9006) as single agent in patients (pts) with unresectable or metastatic gallbladder cancer or cholangiocarcinomas. [Abstract] J Clin Oncol 25 (Suppl 18): A-4639, 2007.

Study ID Numbers: CDR0000444959, SWOG-S0514
Study First Received: October 12, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00238212     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the gallbladder
adenocarcinoma with squamous metaplasia of the gallbladder
cholangiocarcinoma of the gallbladder
squamous cell carcinoma of the gallbladder
adenocarcinoma of the extrahepatic bile duct
cholangiocarcinoma of the extrahepatic bile duct
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
recurrent gallbladder cancer
unresectable gallbladder cancer

Study placed in the following topic categories:
Gallbladder Diseases
Cholangiocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Bile Duct Cancer, Extrahepatic
Squamous Cell Carcinoma
Protein Kinase Inhibitors
Recurrence
Carcinoma
Gall Bladder Cancer
Digestive System Diseases
Bile Duct Diseases
Metaplasia
Biliary Tract Diseases
Epidermoid Carcinoma
Gastrointestinal Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Gallbladder Diseases
Cholangiocarcinoma
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Digestive System Diseases
Bile Duct Diseases
Therapeutic Uses
Biliary Tract Diseases
Gallbladder Neoplasms
Bile Duct Neoplasms
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009