Clinical trialPhase 2Terminated
Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer
A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer
- Outcome
- Stopped earlyStudy was terminated due to poor accrual (Enrollment)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- December 2006
- Expected end
- December 2009
- Enrollment
- 9 participants
- Sites
- 1
- Primary outcomes
- Overall Survival Rate at 6 Months
- Sponsor
- Nih
- Results posted
- 2011-07-15
- Last update
- 31 October 2019
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To evaluate overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in patients who previously received 1 prior regimen for metastatic pancreatic cancer. SECONDARY OBJECTIVES: I. To evaluate the objective tumor response rate, the duration of response, time to tumor progression, and overall survival. II. To evaluate biological effects on peripheral blood mononuclear cells. III. To evaluate the safety profile of this combination. IV. To evaluate archival tissue for epithelial-to-mesenchymal transition (EMT) and E-cadherin and Zeb-1. OUTLINE: Patients receive bortezomib intravenously (IV) on days 1, 4, 8, and 11 and carboplatin intravenously (IV) over 30 minutes on day 1. 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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival Rate at 6 Months [up to 6 months]. Number, Proportion of participants. Bortezomib + Carboplatin (n=9): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Response Rate [from assignment of treatment until the date of first documented progression, assessed up to 17 months]. Count Of Participants, Participants. Bortezomib + Carboplatin (n=9): 0.