Combination Chemotherapy in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00007878

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: bortezomib Drug: fluorouracil Drug: leucovorin calcium	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Bortezomib Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Study of PS-341 in Combination With 5-FU/LV in Solid Tumors

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

Study Start Date:	December 2000
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose and dose-limiting toxicity of bortezomib in combination with leucovorin calcium and fluorouracil in patients with advanced solid tumors.
Determine the pharmacodynamics of bortezomib, in terms of 20S proteasome and NFkB inhibition, in patients treated with this regimen.
Determine the objective tumor response in these patients.
Determine the correlation between 20S proteasome and NFkB inhibition and clinical toxicity in these patients.
Determine the pharmacokinetics of fluorouracil in combination with bortezomib in these patients.

OUTLINE: This is a multicenter, dose-escalation study of bortezomib.

Patients receive bortezomib IV on days 1 and 4 and fluorouracil IV and leucovorin calcium IV on day 1 weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 15 to 30 patients will be accrued for this study within 1 year.

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 metastatic or unresectable solid tumor not amenable to standard therapy
No brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

At least 3 months

Hematopoietic

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

Hepatic

Bilirubin no greater than normal
AST/ALT no greater than 2.5 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
No EKG evidence of acute ischemia or significant conduction abnormality
No history of cardiac or cerebrovascular disease due to hypotension and tachycardia

Other

No other concurrent uncontrolled illness
No ongoing or active infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 4 weeks since prior immunotherapy and recovered

Chemotherapy

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy and recovered

Surgery

At least 2 weeks since prior major surgery

Other

No other concurrent investigational agents
No concurrent antiretroviral therapy (HAART) for HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007878

Locations

United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Heinz-Josef Lenz, MD

Norris Comprehensive Cancer Center

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000068327, CHNMC-PHI-27, LAC-USC-0C003, NCI-T99-0048
Study First Received:	January 6, 2001
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00007878 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Antimetabolites
Calcium, Dietary
Vitamin B Complex
Immunologic Factors
Vitamins
Fluorouracil

Bortezomib
Leucovorin
Trace Elements
Micronutrients
Immunosuppressive Agents
Protease Inhibitors

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Bortezomib
Physiological Effects of Drugs

Leucovorin
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Protease Inhibitors
Vitamins
Fluorouracil
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on May 06, 2009