Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors
Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227)
4 other identifiers
interventional
17
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 breast-cancer
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
February 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedNovember 29, 2017
November 1, 2017
1.9 years
February 20, 2008
November 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose of bortezomib and gemcitabine
A minimum of a 3 week period (1 cycle) must be completed by all patients within a dose level before dose escalation to the next level may occur. A cycle is defined as treatment day 1 and 8 with follow-up through day 21.
Day 21 (Week 3 - Cycle 1)
Secondary Outcomes (3)
Toxicity
30 Days after Last Treatment
Disease response as measured by RECIST criteria
Week 4
Characterization of gemcitabine and metabolite pharmacokinetics (as part of co-enrollment in Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors")
Pre-Dose
Study Arms (1)
Gemcitabine / Bortezomib
EXPERIMENTALGemcitabine 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
- +11 more criteria
You may not qualify if:
- Symptomatic brain metastases
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arkadiusz Dudek, MD
Masonic Cancer Center, University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2008
First Posted
February 21, 2008
Study Start
March 1, 2007
Primary Completion
February 1, 2009
Study Completion
October 1, 2009
Last Updated
November 29, 2017
Record last verified: 2017-11