Status:
COMPLETED
Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Breast Cancer
Colorectal Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE1
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 gemcitabin...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of weekly bortezomib and gemcitabine in treating elderly patients with advanced solid tumors. Secondary * To characterize the quantita...
Eligibility Criteria
Inclusion
- 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 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00620295
Start Date
March 1 2007
End Date
October 1 2009
Last Update
November 29 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455