Study of Temsirolimus, Topotecan, and Bortezomib
A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients With Advanced Malignancy
1 other identifier
interventional
80
1 country
1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of Torisel (temsirolimus), Hycamtin (topotecan hydrochloride), and Velcade (bortezomib) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2008
Longer than P75 for phase_1
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
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 13, 2013
February 1, 2013
4.2 years
October 9, 2008
February 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of combination treatment with temsirolimus, topotecan, and bortezomib
MTD is defined as the highest dose in which the incidence of a dose limiting toxicity (DLT) is \< 33%.
21 days
Study Arms (2)
Torisel + Hycamtin + Velcade
EXPERIMENTALTorisel starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle. Hycamtin starting Dose 0.8 mg/m\^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle. Velcade starting Dose 0.3 mg/m\^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle.
Expansion Group
EXPERIMENTALTorisel + Hycamtin + Velcade Expansion Group Addition of 10 participants at highest tolerated dose level
Interventions
Starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle
Starting Dose 0.8 mg/m\^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle
Starting Dose 0.3 mg/m\^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle
Eligibility Criteria
You may qualify if:
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months
- Patients should be at least four weeks or 5 half lives from the last day of chemotherapy, and antibody or other biological therapy, whichever is shorter.
- Patients should be at least four weeks from the last day of therapeutic radiation.
- The Eastern Cooperative Oncology Group (ECOG) performance status \</= 2 or Karnofsky \>/= 60%.
- Patients must have allowable organ and marrow function defined as: Absolute neutrophil count \>/= 1,000/mL, Platelets \>/=75,000/mL, Serum creatinine \</= 2 \* Upper Limit of Normal (ULN), Total bilirubin \</= 2 \* ULN, aminotransferase (ALT or SGPT) \</= 3 \* ULN, Fasting total cholesterol \<= 350 mg/dL and triglyceride level \<= 400 mg/dL.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and will be advised to avoid pregnancy for 3 months after completion of therapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies except for continuing on hormonal therapy in cases of prostate cancer.
- Treatment on this study may begin within 24 hours after Phase 0 dose of temsirolimus.
You may not qualify if:
- Patients with hemoptysis within 28 days prior to entering the study.
- Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.
- Patients with clinically significant cardiovascular disease: • History of CVA within 6 months • Myocardial infarction or unstable angina within 6 months • Unstable angina pectoris
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
- Pregnant or lactating women.
- History of hypersensitivity to bortezomib or any component of the bortezomib formulation.
- History of hypersensitivity to topotecan or any component of the topotecan formulation.
- History of hypersensitivity to temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any component of the formulation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Karp, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 10, 2008
Study Start
September 1, 2008
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 13, 2013
Record last verified: 2013-02