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Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00027898   Information provided by National Cancer Institute (NCI)
First Received: December 7, 2001   Last Updated: May 12, 2009   History of Changes

December 7, 2001
May 12, 2009
September 2001
 
 
 
Complete list of historical versions of study NCT00027898 on ClinicalTrials.gov Archive Site
 
 
 
Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
A Phase I Study of PS-341 (NSC 681239), Carboplatin, and Etoposide in Patients With Advanced Solid Tumors Refractory to Standard Therapy

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with carboplatin and etoposide in treating patients who have advanced solid tumors that have not responded to previous treatment.

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of bortezomib, carboplatin, and etoposide in patients with advanced solid tumors refractory to standard therapy.
  • Evaluate biologic effects of bortezomib on relevant targets in the tumor tissues of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of bortezomib, etoposide, and carboplatin.

Patients receive bortezomib IV on days 1 and 8, carboplatin IV over 30 minutes on day 1, and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for at least 2 courses 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 or more of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6 additional patients with newly diagnosed, chemotherapy-naive extensive stage small cell lung cancer, and 6 patients with other tumor types, are treated at that dose.

PROJECTED ACCRUAL: A total of 12-27 patients will be accrued for this study within 6-14 months.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: bortezomib
  • Drug: carboplatin
  • Drug: etoposide
 
Lieu C, Chow L, Pierson AS, Eckhardt SG, O'Bryant CL, Morrow M, Tran ZV, Wright JJ, Gore L. A phase I study of bortezomib, etoposide and carboplatin in patients with advanced solid tumors refractory to standard therapy. Invest New Drugs. 2009 Feb;27(1):53-62. Epub 2008 Jul 11.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced solid tumor cancer for which no curative therapy exists
  • Clinically stable CNS disease is allowed provided the following criteria are met:

    • No uncontrolled brain metastases or CNS involvement
    • No active seizures
    • On stable dose of antiseizure or steroid medication for at least 7 days before study enrollment

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 9 g/dL
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST/ALT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No other serious concurrent systemic disorders (including other malignancy)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow or peripheral blood stem cell transplantation
  • No concurrent immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior carboplatin and/or etoposide allowed
  • No more than 2 prior courses of mitomycin

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • Palliative radiotherapy involving less than 35% bone marrow reserve allowed if completed at least 2 weeks before study enrollment
  • No prior wide-field radiotherapy to 35% or more of bone marrow
  • No prior pelvic radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • At least 28 days since prior investigational agents
  • No other concurrent experimental medications
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00027898
 
CDR0000069091, UCHSC-COMIRB-01288, NCI-3171
University of Colorado at Denver and Health Sciences Center
National Cancer Institute (NCI)
Principal Investigator: Lia Gore, MD, FAAP University of Colorado at Denver and Health Sciences Center
National Cancer Institute (NCI)
December 2005

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