Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer - Full Text View

Sponsors and Collaborators:	New York University School of Medicine National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066625

Purpose

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.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: bortezomib Drug: oxaliplatin	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Oxaliplatin Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I And Pharmacokinetic Study Of Oxaliplatin (Eloxatin) In Combination With Bortezumib (PS-341, VELCADE) In Patients With Advanced Malignancy

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

Estimated Enrollment:	30
Study Start Date:	October 2003

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066625

Locations

United States, New York
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Howard S. Hochster, MD

New York University School of Medicine

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Kobrinsky B, Kosloff RA, Wright J, et al.: Neurotoxicity assessment in a phase I bortezomib with oxaliplatin trial. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-951, 2007.

Kosloff RA, Wright J, Ivy P, et al.: Phase I study of bortezomib and oxaliplatin (BOX) in solid tumors: improved neurotoxicity (NT) profile with lower bortezomib (B) dose. [Abstract] J Clin Oncol 24 (Suppl 18): A-12007, 596s, 2006.

Study ID Numbers:	CDR0000316444, NYU-0212, NCI-5736
Study First Received:	August 6, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00066625
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Oxaliplatin
Bortezomib

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009