Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Unresectable, Metastatic Cancer of the Esophagus or Gastroesophageal Junction
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with paclitaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with unresectable, metastatic cancer of the esophagus or gastroesophageal junction.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for Metastatic Adenocarcinoma of the Lower Esophagus, Gastroesophageal Junction, and Gastric Cardia|
- Confirmed tumor response rate [ Designated as safety issue: No ]
- Time to tumor progression [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
- Determine the confirmed tumor response rate in patients with unresectable, metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with bortezomib, paclitaxel, and carboplatin.
- Determine the time to tumor progression, overall survival, and duration of response in patients treated with this regimen.
- Determine the adverse events in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 17 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107341
|Study Chair:||Aminah Jatoi, MD||Mayo Clinic|
|Investigator:||Shaker R. Dakhil, MD, FACP||CCOP - Wichita|
|Investigator:||Cynthia X. Ma, MD, PhD||Washington University Siteman Cancer Center|