Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer (NCT00416793) | Clinical Trial Compass
TerminatedPhase 2
Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer
Stopped: Study was terminated due to poor accrual
United States9 participantsStarted 2006-12
Plain-language summary
This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as 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 carboplatin may kill more tumor cells.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed adenocarcinoma or carcinoma of the pancreas that is metastatic and not amenable to resection with curative intent
* Patients must have measurable disease defined by RECIST criteria; for the purpose of this study, primary mass in the pancreas is not considered as measurable disease
* Patients must have received one (1), and only one, prior systemic regimen for metastatic disease; patients who have received prior cisplatin or oxaliplatin are eligible; a systemic regimen administered for unresectable locally advanced disease that subsequently progressed to metastatic will be counted as 1 prior regimen; chemotherapy administered as adjuvant therapy or as a radiation sensitizer is not counted as a prior regimen
* Prior radiation is permitted; however, at least 3 weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all associated toxicities to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 ≤ Grade 1 at the time of registration; measurable disease must be outside the previous radiation field or a new lesion inside the port must be present
* At least two weeks must have elapsed since any major surgery and patients must have recovered from all associated toxicities to ≤ CTCAE Grade 1 at the time of registration
* At least 4 weeks must have elapsed since previous chemotherapy except for regimens that are administered on a d…