Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00478140|
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : November 19, 2013
Last Update Posted : May 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Extrahepatic Bile Duct Adenocarcinoma of the Gallbladder Malignant Neoplasm Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer||Biological: trastuzumab Other: laboratory biomarker analysis||Phase 2|
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).
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.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Trastuzumab (NSC 688097) in Her2/Neu Positive Cancer of the Gallbladder or Biliary Tract (NCI 7756)|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
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.
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: laboratory biomarker analysis
- Objective Response (Complete and Partial Response) [ Time Frame: Baseline to 63 days or until disease progression ]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.
- Disease Control Rate [ Time Frame: Up to 3.5 years ]Percentage of participants who have achieved complete response, partial response and stable disease
- Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Up to 3 years ]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.
- Overall Survival [ Time Frame: Up to 3.5 years ]Length of time from date of starting treatment that participants are still alive
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478140
|United States, California|
|University of Southern California, Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|United States, Texas|
|The University of Texas (UT) MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ahmed Kaseb||M.D. Anderson Cancer Center|