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A Phase I Study of PS-341 (NSC 681239), Carboplatin, and Etoposide in Patients With Advanced Solid Tumors Refractory to Standard Therapy

Phase 1
16 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of PS-341 (NSC 681239), Carboplatin, and Etoposide in Patients With Advanced Solid Tumors Refractory to Standard Therapy


I. Determine the maximum tolerated dose (MTD) of bortezomib, carboplatin, and etoposide in
patients with advanced solid tumors refractory to standard therapy.

II. 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

Inclusion Criteria:

- Histologically confirmed advanced solid tumor cancer for which no curativetherapy

- 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

- Performance status - ECOG 0-2

- At least 12 weeks

- Absolute neutrophil count at least 1,500/mm^3

- Hemoglobin at least 9 g/dL

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 1.5 mg/dL

- AST/ALT no greater than 2.5 times upper limit of normal

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- 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)

- No prior bone marrow or peripheral blood stem cell transplantation

- No concurrent immunotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and

- Prior carboplatin and/or etoposide allowed

- No more than 2 prior courses of mitomycin

- See Disease Characteristics

- No concurrent hormonal therapy

- 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

- At least 28 days since prior investigational agents

- No other concurrent experimental medications

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD defined as the dose level below the dose level that results in DLT in >= 2 of 6 new patients assessed using NCI CTC version 2.0

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Lia Gore

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Food and Drug Administration

Study ID:




Start Date:

January 2002

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms



University of Colorado Denver, Colorado  80217