Study of Temsirolimus, Topotecan, and Bortezomib - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00770731

Purpose

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.

Condition	Intervention	Phase
Advanced Cancer	Drug: Torisel (Temsirolimus) Drug: Hycamtin (Topotecan) Drug: Velcade (Bortezomib)	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Topotecan hydrochloride Topotecan Bortezomib CCI 779 Deoxyglucose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients With Advanced Malignancy

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study the safety of this drug combination. [ Time Frame: 6 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Torisel + Hycamtin + Velcade	Drug: Torisel (Temsirolimus) Starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle Drug: Hycamtin (Topotecan) Starting Dose 0.8 mg/m^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle Drug: Velcade (Bortezomib) Starting Dose 0.3 mg/m^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle
2: Experimental Torisel + Hycamtin + Velcade Expansion Group Addition of 10 participants at highest tolerated dose level	Drug: Torisel (Temsirolimus) Starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle Drug: Hycamtin (Topotecan) Starting Dose 0.8 mg/m^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle Drug: Velcade (Bortezomib) Starting Dose 0.3 mg/m^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

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.
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 x ULN, Total bilirubin </= 2 x ULN, AST(SGOT) & ALT(SGPT) </= 3 x 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.

Exclusion:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770731

Contacts

Contact: Razelle Kurzrock, MD, BS

713-794-1226

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Razelle Kurzrock, MD, BS

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Razelle Kurzrock, MD, BS

UT MD Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	UT MD Anderson Cancer Center ( Razelle Kurzrock, MD, BS/Professor )
Study ID Numbers:	2008-0425
Study First Received:	October 9, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00770731
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Torisel
Temsirolimus
Hycamtin
Topotecan hydrochloride

Velcade
Bortezomib
FDG-PET Scans
18F-Fluoro-2-Deoxyglucose Positron Emission Tomography

Study placed in the following topic categories:

Sirolimus
Clotrimazole
Miconazole
Bortezomib

Tioconazole
Deoxyglucose
Topotecan

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on January 16, 2009