Phase 2
Completed N=35
Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Source: ClinicalTrials.gov NCT00948935 ↗Enrolled (actual)
35
Serious AEs
60.0%
Results posted
Jun 2019
Primary outcomePrimary: Progression Free Survival Rate at Five Months — 69 percentage of participants
Summary
This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival Rate at Five Months |
69 | — |
| SECONDARY Response Rate From Combination Chemotherapy |
2; 9; 15; 2; 7 | — |
Eligibility Criteria
Inclusion Criteria
- histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract
- measurable disease
- available tumor tissue for investigational immunohistochemical evaluations
- ECOG PS 0-2
- No prior chemotherapy, biologic therapy or radiation therapy
- Age Eighteen and older
- Lab values per protocol
Exclusion Criteria
- Life expectancy less than three months
- Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment
- Prior therapy, which affects or targets the EGF pathway
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- Recovery from major surgery within three weeks of the start of study treatment
Data sourced from ClinicalTrials.gov (NCT00948935). 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. Informational only — not medical advice.