Know Cancer

or
forgot password

A Phase I and Pharmacodynamic Study of Proteasome Inhibitor, PS-341, in Combination With Doxorubicin in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I and Pharmacodynamic Study of Proteasome Inhibitor, PS-341, in Combination With Doxorubicin in Patients With Advanced Solid Tumors


OBJECTIVES:

- Determine the maximum tolerated dose of PS-341 in combination with doxorubicin in
patients with advanced solid tumors.

- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.

- Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of PS-341.

Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11; and doxorubicin IV on
over 3-5 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 3-31 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed advanced solid tumor for which no curative
treatment exists

- Measurable or evaluable disease

- No brain metastases or primary brain tumors

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- MUGA at least 45%

Other:

- No serious active infection

- No pre-existing neuropathy grade 2 or greater

- No other concurrent illness that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 4 weeks since prior chemotherapy

- No prior cumulative dose of doxorubicin exceeding 280 mg/m^2

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy

Surgery:

- Not specified

Other:

- No other concurrent investigational or commercial agents for treatment of this
malignancy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James P. Thomas, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068870

NCT ID:

NCT00023855

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792