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PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors



PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors

For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): University of Wisconsin Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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 PS-341 and doxorubicin in treating patients who have advanced solid tumors.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JamesThomas,  Study Chair,  University of Wisconsin Comprehensive Cancer Center

University of Wisconsin Comprehensive Cancer Center
Madison,  Wisconsin,  53792-6164
United States
 


Additional Information:
Study ID Numbers:  CDR0000068870;  WCCC-CO-01901,NCI-3771
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023855

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
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2. UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors

3. 3-AP in Treating Patients With Advanced Cancer

4. Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy

5. Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer

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