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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| 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: | Treatment, Open Label |
| Official Title: | A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer |
| Estimated Enrollment: | 39 |
| Study Start Date: | December 2006 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin 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 |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma or carcinoma of the pancreas that is metastatic and not amenable to resection with curative intent
Measurable disease
Must have received 1 (and only 1) prior systemic regimen for metastatic disease
No known brain metastases
PATIENT CHARACTERISTICS:
No significant history of cardiac disease, including any of the following:
No other prior malignancy requiring active treatment
PRIOR CONCURRENT THERAPY:
No other concurrent anticancer treatment, including any of the following:
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
| Study ID Numbers: | CDR0000522739, MDA-2006-0079 |
| Study First Received: | December 27, 2006 |
| Last Updated: | December 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00416793 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the pancreas stage IV pancreatic cancer recurrent pancreatic cancer |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Bortezomib Endocrine System Diseases Enzyme Inhibitors Carboplatin |
Pharmacologic Actions Protease Inhibitors Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Endocrine Gland Neoplasms |