Trials / Terminated
TerminatedNCT00478140
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)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | trastuzumab | 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 | Correlative studies |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2011-11-01
- Completion
- 2011-11-01
- First posted
- 2007-05-24
- Last updated
- 2019-08-20
- Results posted
- 2013-11-19
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00478140. Inclusion in this directory is not an endorsement.