Phase 2
N=39
Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy
Extrahepatic Bile Duct Cancer · Gallbladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00919061 ↗Enrolled (actual)
39
Serious AEs
61.5%
Results posted
Feb 2016
Primary outcome: Primary: Progression-Free Survival — 51 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Cisplatin (Drug); Sorafenib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival |
51 | — |
| PRIMARY Median PFS |
6.5; 14.4 | — |
Summary
The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers.
Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. We are looking to improve treatment results. We will attempt to do so by adding sorafenib (a type of monoclonal antibody) to your treatment plan. Sorafenib acts by attaching to blocking specific targets on cells. These targets may help the cancer cells grow and divide. This study will help answer the question of whether sorafenib is a helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.
This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, sorafenib in combination with gemcitabine and cisplatin has on advanced bile duct and gallbladder cancers.
Eligibility Criteria
Inclusion Criteria
- Histologically / cytologically verified, non-resectable, recurrent, or metastatic biliary tract carcinoma including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma. Combined cholangiocarcinoma and hepatocellular carcinoma is allowed.Patients must have uni-dimensionally measurable disease by x-ray, CT scan, MRI scan or physical examination.
- KPS ≥ 80%
- Age ≥ 18 years
- Adequate bone marrow function defined as: Hb ≥ 8 g/dl, ANC ≥ 1.5 K/mcL, Platelets ≥ 100 K/mcL
- Adequate renal function defined as Serum creatinine 150/100 mm Hg
- Significant cardiovascular disease including congestive heart failure (New York Heart Association Class II or higher) or active angina pectoris.
- History of a myocardial infarction within 6 months.
- History of a stroke or transient ischemic attack within 6 months.
- Clinically significant peripheral vascular disease.
- Evidence of bleeding diathesis or coagulopathy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks.
- Uncontrolled infection.
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Pregnant (positive pregnancy test)
- Breast-feeding should be discontinued if the mother is to be treated on clinical trial.
- Serious non-healing wound, ulcer, or bone fracture
- Use of St. John's Wort or rifampin (rifampicin)
- Any condition that impairs patient's ability to swallow whole pills
- Any malabsorption problem
Data sourced from ClinicalTrials.gov (NCT00919061). 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.