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Study Summary
No. 2008-0425:.......Advanced Cancers......Daniel Karp......Investigational Cancer Therapeutics
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Study Summary Title
Study Summary
Number:		2008-0425
Study Title:A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients with Advanced Malignancy
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Physician New Patient Referral
Name:Daniel KarpPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Investigational Cancer TherapeuticsReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-1226
Contact us about clinical trials
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General Information
Disease Group:Advanced CancersSupported By:N/A
Phase of Study:Phase IReturn
Visit:		Patients will return to clinic on Days 1, 4, 8, 11, 15 and 21 of each cycle.
Treatment
Agents:		Bortezomib
Temsirolimus
Topotecan		Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		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.
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Study Objectives / Outcomes
Primary objective:
  • To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of combination treatment with bortezomib, temsirolimus, and topotecan.

Secondary objectives:
  • Preliminary descriptive assessment of anti-tumor efficacy.
  • Assessment of biological and anti-angiogenesis correlates.
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Study Status Information
Study Activation / Registration Date:09/04/2008
IRB Review and Approval Date:09/04/2008
Study Type:Phase I
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) 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

2) 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.

3) Patients should be at least four weeks from the last day of therapeutic radiation.

4) ECOG performance status </= 2 or Karnofsky >/= 60%.

5) Patients must have allowable organ and marrow function defined as:  Absolute neutrophil count >/= 1,000/mL  Platelets >/=75,000/mL  Serum creatinine </= 2 x ULN  Total bilirubin </= 2 x ULN  ALT(SGPT) </= 3 x ULN  Fasting total cholesterol <= 350 mg/dL and triglyceride level <= 400 mg/dL.

6) 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.

7) Ability to understand and the willingness to sign a written informed consent document.

8) 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.

9) Treatment on this study may begin within 24 hours after Phase 0 dose of temsirolimus.
Exclusion Criteria:1) Patients with hemoptysis within 28 days prior to entering the study.

2) Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.

3) Patients with clinically significant cardiovascular disease: • History of CVA within 6 months • Myocardial infarction or unstable angina within 6 months • Unstable angina pectoris

4) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.

5) Pregnant or lactating women.

6) History of hypersensitivity to bortezomib or any component of the bortezomib formulation.

7) History of hypersensitivity to topotecan or any component of the topotecan formulation.

8) History of hypersensitivity to temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any component of the formulation.
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Links
Registration Number: NCT00770731
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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