- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00478140
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
A Phase II Study Trastuzumab (NSC 688097) in Her2/Neu Positive Cancer of the Gallbladder or Biliary Tract (NCI 7756)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. Determine the objective response rate and duration of objective response in patients with HER2/neu-positive advanced gallbladder or biliary tract cancer treated with trastuzumab (Herceptin).
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of this drug in these patients. II. Assess the progression-free survival and overall survival of patients treated with this drug.
OUTLINE:
Patients receive trastuzumab intravenously over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90033
- University of Southern California, Norris Comprehensive Cancer Center
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-
Texas
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Houston, Texas, United States, 77030
- The University of Texas (UT) MD Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Criteria:
- Adenocarcinoma of the gallbladder
- Recurrent extrahepatic bile duct cancer
- Recurrent gallbladder cancer
- Unresectable extrahepatic bile duct cancer
- Adenocarcinoma of the extrahepatic bile duct
- Unresectable gallbladder cancer
- Prior surgery and radiotherapy allowed
- At least 28 days since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) and recovered
- No other concurrent investigational agents, chemotherapy, radiotherapy, or hormonal therapy
- Concurrent hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed
- No concurrent corticosteroids or anticonvulsants
- Concurrent steroids administered for antiemesis, adrenal failure, or septic shock allowed
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Histologically or cytologically confirmed adenocarcinoma of the gallbladder or bile duct, meeting all of the following criteria: locally advanced or metastatic disease that is unresectable
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral computed tomography (CT) scan
- Tumor that recurs within a previously irradiated field is considered measurable disease if recurrence is documented and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Tumor must be Her2/neu positive by Fluorescence in situ hybridization (FISH)testing
- No symptomatic brain metastases
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Fertile patients must use effective contraception prior to, during, and for >= 3 months after completion of study treatment
- Creatinine =< 2 times upper limits of normal (ULN) OR creatinine clearance >= 60 mL/min
- No other active malignancy
- Left Ventricular Ejection Fraction (LVEF) >= 50%
- No concurrent uncontrolled illness
- No ongoing or active infection requiring systemic IV antibiotics on day 1 of treatment
- No symptomatic New York Heart Association class III-IV congestive heart failure
- No unstable angina pectoris
- No unstable cardiac arrhythmia requiring medication
- No more than 1 prior systemic chemotherapy regimen
- White Blood Count (WBC) >= 3,000/mm^3
- Platelet count >= 40,000/mm^3
- Bilirubin =< 4 mg/dL
- Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =< 5 times upper limit of normal (ULN)
- Not pregnant or nursing
- Negative pregnancy test
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trastuzumab
Participants receive trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
For HER-2/neu positive biopsies, trastuzumab was administered intravenously, once every 3 weeks, at a loading first dose at 8 mg/kg over 90 minutes, and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response (Complete and Partial Response)
Time Frame: Baseline to 63 days or until disease progression
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Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles.
Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
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Baseline to 63 days or until disease progression
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control Rate
Time Frame: Up to 3.5 years
|
Percentage of participants who have achieved complete response, partial response and stable disease
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Up to 3.5 years
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Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time Frame: Up to 3 years
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Participant toxicity for study as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 reported in Results Adverse Event Reporting of record.
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Up to 3 years
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Overall Survival
Time Frame: Up to 3.5 years
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Length of time from date of starting treatment that participants are still alive
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Up to 3.5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed Kaseb, M.D. Anderson Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Digestive System Neoplasms
- Gallbladder Diseases
- Biliary Tract Diseases
- Bile Duct Diseases
- Biliary Tract Neoplasms
- Neoplasms
- Recurrence
- Adenocarcinoma
- Cholangiocarcinoma
- Gallbladder Neoplasms
- Bile Duct Neoplasms
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Trastuzumab
Other Study ID Numbers
- NCI-2009-00217
- N01CM62202 (U.S. NIH Grant/Contract)
- 2006-0851
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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