Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors
NCT ID: NCT00620295
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2007-03-31
2009-10-31
Brief Summary
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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.
Detailed Description
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Primary
* To determine the maximum tolerated dose of weekly bortezomib and gemcitabine in treating elderly patients with advanced solid tumors.
Secondary
* To characterize the quantitative and qualitative toxicities of bortezomib and gemcitabine in these patients.
* To obtain preliminary information about the anti-tumor activity of bortezomib and gemcitabine.
* To characterize gemcitabine and metabolite pharmacokinetics in patients receiving concurrent bortezomib therapy.
OUTLINE: This is a phase I dose escalation study of bortezomib and gemcitabine.
Patients receive gemcitabine intravenously (IV) over 30 minutes followed 1 hour later by bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and bortezomib until the maximum tolerated dose of the combination is determined.
Blood is collected periodically for pharmacokinetic and pharmacogenetic studies.
After completion of study treatment, patients are followed every 3 months for up to 1 year.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gemcitabine / Bortezomib
Gemcitabine will be administered as a 30 minute intravenous infusion at the patient's assigned dose on day 1 and day 8 of a 21 day cycle.
Bortezomib will be given 1 hour after gemcitabine by IVP over 3 to 5 seconds followed by a standard saline on days 1 and 8 of a 21 day treatment cycle until disease progression or for a maximum of 6 cycles.
bortezomib
Bortezomib will be given 1 hour after gemcitabine by intravenous pyelogram (IVP) over 3 to 5 seconds followed by a standard saline flush or through a running intravenous (IV) line at the patient's assigned dose (1.0 up to 1.8 mg/m\^2) on days 1 and 8 of a 21 day treatment cycle until disease progression or for a maximum of 6 cycles.
gemcitabine hydrochloride
Gemcitabine will be administered as a 30 minute intravenous infusion at the patient's assigned dose (800 up to 1000 mg/m\^2) on day 1 and day 8 of a 21 day cycle.
Interventions
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bortezomib
Bortezomib will be given 1 hour after gemcitabine by intravenous pyelogram (IVP) over 3 to 5 seconds followed by a standard saline flush or through a running intravenous (IV) line at the patient's assigned dose (1.0 up to 1.8 mg/m\^2) on days 1 and 8 of a 21 day treatment cycle until disease progression or for a maximum of 6 cycles.
gemcitabine hydrochloride
Gemcitabine will be administered as a 30 minute intravenous infusion at the patient's assigned dose (800 up to 1000 mg/m\^2) on day 1 and day 8 of a 21 day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 since prior bortezomib and/or gemcitabine
* At least 2 weeks since prior systemic therapy
* At least 3 weeks since prior investigational agents (for reasons other than the treatment of cancer)
* At least 2 weeks since prior radiotherapy
Exclusion Criteria
* Serious concomitant medical or psychiatric disorders (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
* Myocardial infarction within the past 6 months
* New York Heart Association (NYHA) Class III or IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Peripheral neuropathy ≥ grade 2
* Known hypersensitivity to bortezomib, boron or mannitol
* Prior radiotherapy to ≥ 25% of the bone marrow
* Prior radiotherapy to the whole pelvis
* Concurrent filgrastim (G-CSF) or other hematologic support during course 1 of study treatment
70 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Arkadiusz Dudek, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-2006LS040
Identifier Type: OTHER
Identifier Source: secondary_id
UMN-X05227
Identifier Type: OTHER
Identifier Source: secondary_id
x464
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000586510
Identifier Type: -
Identifier Source: org_study_id