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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00416793 |
Purpose
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 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.
PURPOSE: This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: Bortezomib Drug: Carboplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer |
| Enrollment: | 9 |
| Study Start Date: | December 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bortezomib + Carboplatin
Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
|
Drug: Bortezomib
1.3 mg/m2 by vein (IV) on days 1, 4, 8, and 11
Other Names:
Drug: Carboplatin
AUC = 5 IV over 30 minutes starting 1 hour after completion of Bortezomib on day 1.
Other Name: Paraplatin
|
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Gauri Varadhachary, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00416793 History of Changes |
| Obsolete Identifiers: | NCT00409877 |
| Other Study ID Numbers: | MDA-2006-0079, P30CA016672, MDA-2006-0079, CDR0000522739 |
| Study First Received: | December 27, 2006 |
| Results First Received: | June 14, 2011 |
| Last Updated: | August 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the pancreas stage IV pancreatic cancer recurrent pancreatic cancer |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
Bortezomib Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |