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Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer
This study has been completed.
First Received: December 27, 2006   Last Updated: December 23, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity and safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: December 2006
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Assess overall survival at 6 months in patients with previously treated metastatic pancreatic cancer treated with bortezomib and carboplatin.

Secondary

  • Determine the objective tumor response rate, duration of response, time to tumor progression, and overall survival of patients treated with this regimen.
  • Assess the safety profile of this regimen in these patients.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma or carcinoma of the pancreas that is metastatic and not amenable to resection with curative intent

    • No locally advanced disease
  • Measurable disease

    • Primary mass in the pancreas is not considered measurable disease
    • Measurable disease must be outside a previous radiation field OR a new lesion must be present inside the port
  • Must have received 1 (and only 1) prior systemic regimen for metastatic disease

    • Chemotherapy administered as adjuvant therapy or radiation sensitization is not considered a regimen if it was received ≥ 6 months ago
    • A systemic regimen administered for unresectable locally advanced disease that subsequently progressed to metastatic will be counted as 1 prior regimen
  • No known brain metastases

    • Brain imaging studies are not required if patient has no neurological signs or symptoms of brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastasis is present)
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
  • No significant history of cardiac disease, including any of the following:

    • Unstable angina
    • New York Heart Association class III or IV congestive heart failure
    • Myocardial infarction within the past 6 months
  • No neurotoxicity > grade 1
  • No other prior malignancy requiring active treatment

    • No radiographic evidence of a second malignancy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior cisplatin or oxaliplatin allowed
  • At least 3 weeks since prior radiation therapy and recovered
  • At least 2 weeks since prior major surgery and recovered
  • At least 4 weeks since prior chemotherapy (2 weeks for chemotherapy administered on a daily or weekly schedule) and recovered
  • No prior carboplatin, bortezomib, or another proteasome inhibitor
  • No other concurrent anticancer treatment, including any of the following:

    • Chemotherapy
    • Radiation therapy
    • Biologic agents
    • Other investigational drugs
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Adjuvant hormonal therapy for breast cancer or prostate cancer allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416793

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Gauri Varadhachary, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage IV pancreatic cancer
recurrent pancreatic cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010