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PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors - Article


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Chemotherapy

Cancer Chemotherapy


Clinical Trial: PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

This study is no longer recruiting patients.

Sponsors and Collaborators: Mayo Clinic Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: PS-341 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 PS-341 and chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining PS-341 and combination chemotherapy in treating patients who have advanced solid tumors.

Condition Treatment or Intervention Phase
unspecified adult solid tumor, protocol specific
 Drug: bortezomib
 Drug: carboplatin
 Drug: paclitaxel
 Procedure: chemotherapy
 Procedure: enzyme inhibitor therapy
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of PS-341, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a dose-escalation study of PS-341 and paclitaxel. Patients are assigned to 1 of 2 treatment groups.

  • Group A: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and PS-341 IV over 3-5 seconds on days 2, 5, and 8.
  • Group B: Patients receive PS-341 IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Treatment in both groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. After 6 courses of paclitaxel and carboplatin, patients with stable or responding disease may continue with PS-341 alone at the discretion of the investigator.

Cohorts of 3-6 patients in each group receive escalating doses of PS-341 and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 24-96 patients will be accrued for this study within 25 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
  • No hematologic malignancies
  • No symptomatic CNS metastases
  • Brain metastases allowed if previously treated (radiotherapy and/or surgery) and patient is stable for at least 8 weeks

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • HIV negative
  • No peripheral neuropathy grade 2 or greater
  • No uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • More than 4 weeks since prior biologic therapy
  • More than 4 weeks since prior immunotherapy
  • No prior bone marrow transplantation
  • No concurrent immunotherapy

Chemotherapy:

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to more than 30% of bone marrow
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent investigational ancillary therapy
  • No concurrent enrollment in another study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy) for symptom control or therapeutic intents

Location Information


Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States

Study chairs or principal investigators

Alex A. Adjei, MD, PhD,  Study Chair,  Mayo Clinic Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069108; MAYO-MC0012; NCI-1860
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028587
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: October 3, 2005
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