At a glance
ClinicalIndex Comparison Record- ✓Measurable, histologically confirmed advanced unresectable or metastatic gastric or GEJ adenocarcinoma with imaging within 4 weeks of entry
- ✓ECOG performance status 0-1
- ✓Prior adjuvant chemotherapy or chemoradiation allowed if completed >6 months before recurrent or metastatic disease
- ✓Adequate baseline laboratory values: ANC ≥1,500/mm³, platelets ≥100,000/mm³, WBC ≥3,000/mm³, creatinine ≤1.5 mg/dl, total bilirubin ≤2.0 mg/dl, AST/ALT/alk phos ≤2.5× ULN
- ✕Prior radiotherapy, chemotherapy, or investigational therapies (particularly tyrosine kinase inhibitors, signal transduction or angiogenesis inhibitors) for recurrent and/or metastatic gastric or GEJ adenocarcinoma
- ✕Brain metastases
- ✕History of allergic reactions to compounds of similar chemical or biologic composition to sorafenib
- ✕Uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/addictive disorders that would limit compliance
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined With Docetaxel and Cisplatin or Oxaliplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating BAY 43-9006, docetaxel, and 1 other intervention for Adenocarcinoma of the Gastroesophageal Junction and 2 related conditions. Completed, enrolled 44 participants across 1 site.
Detailed Summary
This phase II trial is studying how well giving sorafenib together with docetaxel and cisplatin works in treating patients with metastatic or locally advanced gastric or gastroesophageal junction cancer that cannot be removed by surgery. 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 docetaxel and cisplatin, 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 docetaxel and cisplatin may kill more tumor cells.
Study Details
Timeline
Interventions
Given orally
Given IV
Given IV