Phase 2
N=56
Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
Cholangiocarcinoma of the Extrahepatic Bile Duct · Cholangiocarcinoma of the Gallbladder · Gastrointestinal Cancer · Recurrent Extrahepatic Bile Duct Cancer · Recurrent Gallbladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00356889 ↗Enrolled (actual)
56
Serious AEs
40.0%
Results posted
May 2013
Primary outcome: Primary: Number of Confirmed Tumor Responses. — 6; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- erlotinib hydrochloride (Drug); bevacizumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Confirmed Tumor Responses. |
6; 0 | — |
| SECONDARY Survival Time |
9.9 | — |
| SECONDARY Time to Disease Progression |
4.4 | — |
| SECONDARY Duration of Response |
8.4 | — |
Summary
This phase II trial is studying how well giving bevacizumab together with erlotinib hydrochloride works in treating patients with metastatic or unresectable biliary tumors. Monoclonal antibodies, such as bevacizumab, 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. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and erlotinib hydrochloride may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with erlotinib hydrochloride may kill more tumor cells.
Eligibility Criteria
Criteria:
- Absolute neutrophil count >= 1,500/mm3
- Histologically or cytologically confirmed cholangiocarcinoma or gallbladder carcinoma:
- Metastatic or surgically unresectable disease
- Measurable disease, defined as >= 1 lesion whose longest diameter can be accurately measured as >= 2.0 cm with conventional techniques or as > 1.0 cm with spiral CT scan:
- Spiral CT scan imaging must be used for pre- and post-treatment tumor measurements of lesions measuring >= 1.0 cm to = 3 months
- ECOG performance status 0-2
- Platelet count >= 75,000/mm3
- Total bilirubin = = 2.5 g/dL
- Alkaline phosphatase = 1.5 and both of the following criteria are met:
- In-range INR on a stable dose of oral anticoagulant OR on a stable dose of low molecular weight heparin
- AND (continued from above) No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels, gastrointestinal ulcerations, or known varices)
Data sourced from ClinicalTrials.gov (NCT00356889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.