A Study of Combination of Gemcitabine, Oxaliplatin (GEMOX)-Sorafenib in Patients With Advanced Biliary Tract Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Miami
First received: August 6, 2009
Last updated: August 13, 2013
Last verified: August 2013
The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the recommended phase II dose (RPTD). The phase II trial will enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary estimate of progression-free survival (primary endpoint of the trial) in the target population.
Biliary Tract Cancer
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I/II Study of Combination of Gemcitabine, Oxaliplatin and Sorafenib (GEMOX-Sorafenib) in Patients With Advanced Biliary Tract Cancer
Primary Outcome Measures:
- Phase I: Establish the recommended phase II dose (RPTD) of the combination of sorafenib and GEMOX in patients with advanced biliary tract cancer (BTC). [ Time Frame: First two 14-day Phase I cycles ] [ Designated as safety issue: Yes ]
- Phase II: Obtain an estimate of the 9-month progression-free survival rate in patients with advanced BTC receiving the RPTD of the combination sorafenib and GEMOX. [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Phase II: Estimate overall response rate and clinical benefit rate. [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
- Phase II: Estimate overall survival [ Time Frame: Start of treatment until death ] [ Designated as safety issue: No ]
- Phase II: Further evaluate the safety of the proposed combination [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
- Phase II: Explore biomarkers of response to the combination [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
- Phase I: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
- Phase II: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
- Phase I: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
- Phase II: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
- Phase I: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.
- Phase II: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.
Other Name: BAY 43-9006
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Investigational agents within 28 days prior to Day 1 of study
- Chemotherapy within 4 weeks prior to Day 1 of study
- Nitrosoureas, mitomycin-C within 6 weeks prior to Day 1 of study.
- Prior treatment with sorafenib, gemcitabine or oxaliplatin
- Prior history of peripheral neuropathy > Grade 1 (e.g., diabetic neuropathy)
- Pregnant or breast-feeding female
- Patients with a history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to sorafenib, oxaliplatin or gemcitabine
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Known human immunodeficiency virus (HIV) infection and Hepatitis B and Hepatitis C.
- Active clinically serious infection > CTCAE Grade 2.
- Arterial thrombotic/embolic events like myocardial infarct and cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Use of St. John's Wort or rifampin (rifampicin).
- Any medical condition, which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00955721
|University of Miami Sylvester Comprehensive Cancer Center
|Miami, Florida, United States, 33136 |
University of Miami
||Peter Hosein, MD
||University of Miami Sylvelster Comprehensive Cancer Center
No publications provided
||University of Miami
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 6, 2009
||August 13, 2013
||United States: Institutional Review Board
Keywords provided by University of Miami:
Biliary Tract Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protein Kinase Inhibitors