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S0514 Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or Cholangiocarcinoma

Primary Purpose

Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder, Adenocarcinoma With Squamous Metaplasia of the Gallbladder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib tosylate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Extrahepatic Bile Duct

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a cytologically or pathologically confirmed diagnosis of cholangiocarcinoma or gallbladder carcinoma The pathologic confirmation of gallbladder or cholangiocarcinoma may be made from the primary or metastatic site; biopsy of the gallbladder or bile duct mass is not necessary; patients with pathologic confirmation of adenocarcinoma of a metastatic site, along with clinical documentation of gallbladder or bile duct involvement and no evidence of another primary are also eligible; if clinical documentation of gallbladder or bile duct involvement is not possible because of removal of the organ, a clinically and/or radiographically consistent picture plus pathologic findings from the metastatic site that are determined to be consistent with cholangiocarcinoma are acceptable Eligible pathologic type: Patient must have one of the following subtypes: adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, intestinal type, clear cell adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, squamous cell carcinoma, adenosquamous carcinoma, small cell carcinoma, undifferentiated carcinoma, carcinoma NOS; patient must not have carcinoid tumors or sarcomas Patient must have locally advanced or distant metastatic disease that is not surgically curable Patient must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed Institutions are required to submit paraffin-embedded specimens Institutions are required to seek additional patient consent for submission of blood Patient may have had prior surgery, including surgery for their gallbladder or cholangiocarcinoma; patients must be at least 14 days beyond any major surgery, and recovered from all effects of surgery Patient must not have received prior therapy for unresectable or metastatic disease; patient may have received prior chemotherapy, hormonal therapy, immunotherapy, radiation therapy (to less than 25% of bone marrow only) or chemoradiotherapy as neoadjuvant or adjuvant treatment; this must have been completed at least 12 months prior to documented recurrence or metastatic disease; patient must have recovered from all radiation induced toxicities Prior radiation therapy to metastatic sites, such as bone, is allowed as long as the patient has measurable lesion(s) that were not treated with radiation therapy; at least 28 days must have elapsed since completion of radiation therapy, and patient must have recovered from all effects Patient must not have received prior BAY 43-9006 or any inhibitor of VEGFR or the MAPK pathway Patient must have Zubrod performance status of 0-1 Total serum bilirubin =< 3 x the institutional upper limit of normal (IULN) Serum transaminase (SGOT or SGPT) =< 2.5 x IULN; if liver metastasis is present, SGOT or SGPT must be =< 5 x IULN Patients with biliary obstruction must have decompressions of the biliary tree by ERCP and stenting or percutaneous drainage Serum creatinine =< 1.5 x IULN OR measured creatinine clearance >= 60 mL/min OR estimated creatinine clearance >= 60 mL/min Leukocyte count >= 3,000/mcL ANC >= 1,000/mcL Platelets >= 100,000/mcL PT, INR and PTT =< IULN Patients must not be taking the cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, and Phenobarbital), rifampin, or St. Johns Wort Patient must not be on therapeutic anticoagulation; prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices is allowed provided that the requirements for PT, INR and PTT are met Patient must not have any evidence of bleeding diathesis Patients must not have clinically significant cardiac disease that is not well controlled by medication (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within 12 months prior to registration Patient must not have uncontrolled hypertension Patient must not have known brain metastases because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Patient must either be able to swallow and/or receive enteral medications via gastrostomy feeding tube; tablets must not be crushed; patient must have the ability to absorb medication (i.e., no malabsorption syndrome); patient must not have intractable nausea or vomiting Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol; radiation for palliation to metastatic sites is allowed as long gas the target lesions are not irradiated Women/men of reproductive potential must agree to use an adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of protocol treatment; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; pregnant or nursing women are not eligible for this protocol; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding must be discontinued if the mother is treated with BAY 43-9006 HIV-positive patients must have a CD4 count > 500 and must have no active opportunistic infection; in addition, patient must not be receiving combination anti-retroviral therapy No other prior malignancy is allowed except for the following: 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 for five years If day 14, 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday two weeks later would be considered day 14; this allows for efficient patient scheduling without exceeding the guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Sites / Locations

  • Southwest Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Response probability (confirmed complete and confirmed partial responses)

Secondary Outcome Measures

Overall survival
Time to treatment failure
Time to progression

Full Information

First Posted
October 12, 2005
Last Updated
January 11, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00238212
Brief Title
S0514 Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or Cholangiocarcinoma
Official Title
Phase II Study of BAY 43-9006 (NSC #724772) as Single Agent in Unresectable or Metastatic Gallbladder Carcinoma and Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial is studying how well sorafenib works in treating patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma. 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
Detailed Description
PRIMARY OBJECTIVES: I. To assess the objective response probability (complete responses and partial responses) for BAY 43-9006 in patients with unresectable or metastatic gallbladder or cholangiocarcinoma. II. To assess overall survival, time to treatment failure and progression-free survival in these patients. III. To assess quantitative and qualitative toxicities of this regimen. IV. To evaluate in a preliminary fashion relevant prognostic and predictive molecular markers of clinical outcome in gallbladder and cholangiocarcinoma. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder, Adenocarcinoma With Squamous Metaplasia of the Gallbladder, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Squamous Cell Carcinoma of the Gallbladder, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Other Intervention Name(s)
BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response probability (confirmed complete and confirmed partial responses)
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
From date of registration to date of death due to any cause, assessed up to 3 years
Title
Time to treatment failure
Time Frame
From date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment, assessed up to 3 years
Title
Time to progression
Time Frame
From date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration, assessed up to 3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a cytologically or pathologically confirmed diagnosis of cholangiocarcinoma or gallbladder carcinoma The pathologic confirmation of gallbladder or cholangiocarcinoma may be made from the primary or metastatic site; biopsy of the gallbladder or bile duct mass is not necessary; patients with pathologic confirmation of adenocarcinoma of a metastatic site, along with clinical documentation of gallbladder or bile duct involvement and no evidence of another primary are also eligible; if clinical documentation of gallbladder or bile duct involvement is not possible because of removal of the organ, a clinically and/or radiographically consistent picture plus pathologic findings from the metastatic site that are determined to be consistent with cholangiocarcinoma are acceptable Eligible pathologic type: Patient must have one of the following subtypes: adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, intestinal type, clear cell adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, squamous cell carcinoma, adenosquamous carcinoma, small cell carcinoma, undifferentiated carcinoma, carcinoma NOS; patient must not have carcinoid tumors or sarcomas Patient must have locally advanced or distant metastatic disease that is not surgically curable Patient must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed Institutions are required to submit paraffin-embedded specimens Institutions are required to seek additional patient consent for submission of blood Patient may have had prior surgery, including surgery for their gallbladder or cholangiocarcinoma; patients must be at least 14 days beyond any major surgery, and recovered from all effects of surgery Patient must not have received prior therapy for unresectable or metastatic disease; patient may have received prior chemotherapy, hormonal therapy, immunotherapy, radiation therapy (to less than 25% of bone marrow only) or chemoradiotherapy as neoadjuvant or adjuvant treatment; this must have been completed at least 12 months prior to documented recurrence or metastatic disease; patient must have recovered from all radiation induced toxicities Prior radiation therapy to metastatic sites, such as bone, is allowed as long as the patient has measurable lesion(s) that were not treated with radiation therapy; at least 28 days must have elapsed since completion of radiation therapy, and patient must have recovered from all effects Patient must not have received prior BAY 43-9006 or any inhibitor of VEGFR or the MAPK pathway Patient must have Zubrod performance status of 0-1 Total serum bilirubin =< 3 x the institutional upper limit of normal (IULN) Serum transaminase (SGOT or SGPT) =< 2.5 x IULN; if liver metastasis is present, SGOT or SGPT must be =< 5 x IULN Patients with biliary obstruction must have decompressions of the biliary tree by ERCP and stenting or percutaneous drainage Serum creatinine =< 1.5 x IULN OR measured creatinine clearance >= 60 mL/min OR estimated creatinine clearance >= 60 mL/min Leukocyte count >= 3,000/mcL ANC >= 1,000/mcL Platelets >= 100,000/mcL PT, INR and PTT =< IULN Patients must not be taking the cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, and Phenobarbital), rifampin, or St. Johns Wort Patient must not be on therapeutic anticoagulation; prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices is allowed provided that the requirements for PT, INR and PTT are met Patient must not have any evidence of bleeding diathesis Patients must not have clinically significant cardiac disease that is not well controlled by medication (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within 12 months prior to registration Patient must not have uncontrolled hypertension Patient must not have known brain metastases because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Patient must either be able to swallow and/or receive enteral medications via gastrostomy feeding tube; tablets must not be crushed; patient must have the ability to absorb medication (i.e., no malabsorption syndrome); patient must not have intractable nausea or vomiting Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol; radiation for palliation to metastatic sites is allowed as long gas the target lesions are not irradiated Women/men of reproductive potential must agree to use an adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of protocol treatment; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; pregnant or nursing women are not eligible for this protocol; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding must be discontinued if the mother is treated with BAY 43-9006 HIV-positive patients must have a CD4 count > 500 and must have no active opportunistic infection; in addition, patient must not be receiving combination anti-retroviral therapy No other prior malignancy is allowed except for the following: 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 for five years If day 14, 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday two weeks later would be considered day 14; this allows for efficient patient scheduling without exceeding the guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony El-Khoueiry
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Oncology Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245
Country
United States

12. IPD Sharing Statement

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S0514 Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or Cholangiocarcinoma

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