Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00049088

Purpose

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Combining bortezomib with docetaxel may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with docetaxel in treating patients who have advanced solid tumors.

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

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Study Of PS-341 In Combination With Docetaxel In Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel Bortezomib

U.S. FDA Resources

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

Study Start Date:	December 2002
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of bortezomib and docetaxel in patients with advanced solid tumors.
Determine the toxicity and tolerability of this regimen in these patients.
Determine the biologic correlates of proteasome inhibition of bortezomib and determine the effects of this inhibition on the pharmacokinetics of docetaxel in these patients.
Determine the antitumor efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

For course 1, patients receive docetaxel IV over 1 hour on days 1 and 8 and bortezomib IV over 3-5 seconds on days 9 and 12. Patients then receive 1 week of rest. For course 2 and all subsequent courses, patients receive docetaxel on days 1 and 8 and bortezomib on days 2, 5, 9, and 12. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 2-6 patients receive escalating doses of bortezomib and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

PROJECTED ACCRUAL: A minimum of 24 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 confirmed solid tumor 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 50-100%

Life expectancy

More than 12 weeks

Hematopoietic

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 8 g/dL

Hepatic

Bilirubin normal
AST and ALT no greater than 1.5 times upper limit of normal (ULN) and alkaline phosphatase no greater than 2.5 times ULN OR
Alkaline phosphatase no greater than 5 times ULN (unless bone-derived) and AST and ALT less than 1.5 times ULN

Renal

Creatinine normal OR
Creatinine clearance at least 60 mL/min

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 during and for 3 months after study
No prior allergic reactions attributed to taxanes (e.g., docetaxel or paclitaxel) or compounds of similar chemical or biological composition
No prior allergic reactions to compounds similar to bortezomib or other study agents
No known hypersensitivity to corticosteroids
No predicted intolerance to regular, repeated administration of corticosteroids (e.g., poorly controlled diabetes or significant osteoporosis/osteopenia)
No ongoing or active infection
No other uncontrolled concurrent illness that would preclude study participation
No psychiatric illness or social situation that would preclude study participation
No peripheral neuropathy grade 2 or greater

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

At least 4 weeks since prior chemotherapy (6 weeks for carmustine, nitrosoureas, or mitomycin) and recovered
- No more than 3 courses of mitomycin
Prior taxanes allowed
- At least 6 months since prior docetaxel administered on a weekly schedule

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy and recovered

Surgery

Not specified

Other

No other concurrent investigational agents
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent anticancer agents or therapies (commercial or investigational)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049088

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-1000

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Deborah K. Armstrong, MD

Sidney Kimmel 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:	CDR0000257807, JHOC-J0203, NCI-1858
Study First Received:	November 12, 2002
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00049088 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:

Docetaxel
Bortezomib
Protease Inhibitors

Additional relevant MeSH terms:

Docetaxel
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Bortezomib
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on September 11, 2009