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Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer
This study has been completed.
Study NCT00066625   Information provided by National Cancer Institute (NCI)
First Received: August 6, 2003   Last Updated: July 23, 2008   History of Changes

August 6, 2003
July 23, 2008
October 2003
 
 
 
Complete list of historical versions of study NCT00066625 on ClinicalTrials.gov Archive Site
 
 
 
Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer
A Phase I And Pharmacokinetic Study Of Oxaliplatin (Eloxatin) In Combination With Bortezumib (PS-341, VELCADE) In Patients With Advanced Malignancy

RATIONALE: Drugs used in chemotherapy such as oxaliplatin use different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. Combining oxaliplatin with bortezomib may kill more cancer cells.

PURPOSE: Phase I trial to study the effect on the body of combining oxaliplatin with bortezomib in treating patients who have metastatic or unresectable cancer.

OBJECTIVES:

  • Determine the maximum tolerated dose and recommended phase II dose of oxaliplatin and bortezomib in patients with advanced malignancy.
  • Determine the dose-limiting toxicity of this regimen in these patients.
  • Determine the toxicity profile of this regimen in these patients.
  • Determine the antitumor activity of this regimen in these patients.
  • Determine the pattern of neurotoxicity and its reversibility in patients responding to prolonged administration of this treatment regimen.
  • Determine whether the pharmacokinetics and pharmacodynamics of oxaliplatin or bortezomib are altered by the administration of the other agent in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and bortezomib IV over 3-5 seconds on days 1, 4, 15, and 18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and bortezomib until the maximum tolerated doses (MTDs) are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for at least 3 months.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4-15 months.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: bortezomib
  • Drug: oxaliplatin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy for which standard curative or palliative measures do not exist or are no longer effective

    • Metastatic or unresectable disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100

Life expectancy

  • More than 6 months

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT no greater than 5 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to any platinum or other study agents
  • No pre-existing peripheral neuropathy
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior thalidomide allowed provided patient has no clinical neuropathy

Chemotherapy

  • Prior platinum or antitubulin agents allowed provided patient has no clinical neuropathy
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 3 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for the malignancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066625
 
CDR0000316444, NYU-0212, NCI-5736
New York University School of Medicine
National Cancer Institute (NCI)
Principal Investigator: Howard S. Hochster, MD New York University School of Medicine
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP