PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
Phase I trial to study the effectiveness of combining PS-341 and combination chemotherapy in treating patients who have advanced solid tumors. 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
Key facts
- Study ID
- NCT00028587
- Run by
- National Cancer Institute (NCI)
- People needed
- 96
- Starts
- 2001-12-01
- Last updated by the study team
- 2013-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Performance status - ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
- Creatinine no greater than 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- 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
- More than 4 weeks since prior biologic therapy
- More than 4 weeks since prior immunotherapy
- No prior bone marrow transplantation
- No concurrent immunotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No other concurrent chemotherapy
- More than 4 weeks since prior radiotherapy
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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