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Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00049088   Information provided by National Cancer Institute (NCI)
First Received: November 12, 2002   Last Updated: February 25, 2009   History of Changes

November 12, 2002
February 25, 2009
December 2002
February 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00049088 on ClinicalTrials.gov Archive Site
 
 
 
Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
A Phase I Study Of PS-341 In Combination With Docetaxel In Patients With Advanced Solid Tumors

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.

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.

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

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
February 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00049088
 
CDR0000257807, JHOC-J0203, NCI-1858
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Deborah K. Armstrong, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2003

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