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Bortezomib and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors
This study has been completed.
Study NCT00030368   Information provided by National Cancer Institute (NCI)
First Received: February 14, 2002   Last Updated: February 25, 2009   History of Changes

February 14, 2002
February 25, 2009
November 2001
February 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00030368 on ClinicalTrials.gov Archive Site
 
 
 
Bortezomib and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Phase I Study of PS-341 in Combination With Paclitaxel in Metastatic Solid Tumors

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

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

OBJECTIVES:

  • Determine the maximum tolerated dose of bortezomib when given in combination with paclitaxel in patients with locally advanced or metastatic solid tumors.

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

Patients receive bortezomib IV on days 2 and 9 and paclitaxel IV over 1 hour on days 1 and 8. For the first course only, patients do not receive paclitaxel on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 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 or greater than 80% 20S proteasome inhibition. Once the MTD is determined, an additional 6-9 patients are accrued and treated at that dose.

Patients are followed at 21 days.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

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

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
45
 
February 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed locally advanced or metastatic solid tumor for which there is no curative treatment
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • Not specified

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

Hepatic:

  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than ULN

Cardiovascular:

  • Left ventricular function at least lower limit of normal if received prior doxorubicin
  • No grade II or IV tilt-table test
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No thrombotic event within the past 6 months

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reaction to compounds of similar chemical or biological composition to study drugs
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • Prior paclitaxel allowed

Endocrine therapy:

  • At least 2 weeks since prior hormonal therapy
  • No concurrent steroids or hormonal therapy except steroids to prevent hypersensitivity reactions to paclitaxel or hormonal therapy for non-disease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • At least 4 weeks since prior surgery

Other:

  • Recovered from prior therapy
  • No other concurrent investigational agents
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No concurrent anticoagulation therapy
  • Concurrent pamidronate or zoledronate allowed for treatment of hypercalcemia or for palliation of skeletal metastases
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00030368
 
CDR0000069159, OSU-01H0147, NCI-1857
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Study Chair: Charles L. Shapiro, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
April 2007

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