At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic pancreatic carcinoma
- ✓Measurable disease: ≥20 mm (conventional imaging) or ≥10 mm (spiral CT)
- ✓No prior chemotherapy for metastatic disease; prior adjuvant chemotherapy allowed if non-gemcitabine and completed >6 months prior
- ✓Available tumor biopsy specimen (paraffin embedded or fresh frozen) obtained at diagnosis and/or prior to entry
- ✕Brain metastases (excluded due to poor prognosis and confounding neurologic effects)
- ✕Concurrent use of CYP3A inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
- ✕Concurrent investigational agents
- ✕Allergic reaction to sorafenib or gemcitabine or similar agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Study of BAY 43-9006 in Combination With Gemcitabine in Metastatic Pancreatic Carcinoma
In Brief
A Phase 2 clinical trial evaluating sorafenib tosylate, gemcitabine hydrochloride, and 1 other intervention for Stage IV Pancreatic Cancer. Completed, enrolled 52 participants across 1 site.
Detailed Summary
This randomized phase II is studying how well giving sorafenib with or without gemcitabine works in treating patients with metastatic pancreatic cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with gemcitabine may kill more tumor cells.
Study Details
Timeline
Interventions
Given PO
Given IV
Correlative studies