Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors (NCT00620295) | Clinical Trial Compass
CompletedPhase 1
Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors
United States17 participantsStarted 2007-03
Plain-language summary
RATIONALE: Bortezomib may stop the growth of solid tumors by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and gemcitabine in treating older patients with advanced solid tumors.
Who can participate
Age range70 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of advanced non-hematologic malignancy, including any of the following:
* Breast cancer
* Lung cancer
* Colon cancer
* Pancreatic cancer
* Head and neck cancer
* Sarcoma
* Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy (for all diseases except pancreatic cancer)
* Pancreatic cancer patients may be enrolled with no prior therapy requirements since gemcitabine is the current standard of care 1st line therapy
* Measurable or nonmeasurable disease
* Concurrent enrollment in the University of Minnesota study "Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors" (Human Subjects Code 0508M72989) required
* ECOG performance status of 0-1
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement)
* Calculated or measured creatinine clearance \> 30 mL/minute
* Fertile patients must use effective contraception during and for 3 months after study participation
* Recovered from all prior therapy
* Prior systemic chemotherapy, immunotherapy, or biological therapy allowed
* At least 3 months…
What they're measuring
1
Maximum tolerated dose of bortezomib and gemcitabine
Timeframe: Day 21 (Week 3 - Cycle 1)
Trial details
NCT IDNCT00620295
SponsorMasonic Cancer Center, University of Minnesota