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Study of Temsirolimus, Topotecan, and Bortezomib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00770731
First received: October 9, 2008
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Advanced Cancer
 Drug: Torisel (Temsirolimus)
Drug: Hycamtin (Topotecan)
Drug: Velcade (Bortezomib)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients With Advanced Malignancy

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of combination treatment with temsirolimus, topotecan, and bortezomib [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    MTD is defined as the highest dose in which the incidence of a dose limiting toxicity (DLT) is < 33%.


Enrollment: 80
Study Start Date: September 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Torisel + Hycamtin + Velcade

Torisel 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.

 Drug: Torisel (Temsirolimus)
Starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle
Other Names:
  • Temsirolimus
  • CCI-779
Drug: Hycamtin (Topotecan)
Starting Dose 0.8 mg/m^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle
Other Names:
  • Topotecan
  • Topotecan Hydrochloride
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
Other Names:
  • Bortezomib
  • LDP-341
  • MLN341
  • PS-341
Experimental: Expansion Group

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
Other Names:
  • Temsirolimus
  • CCI-779
Drug: Hycamtin (Topotecan)
Starting Dose 0.8 mg/m^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle
Other Names:
  • Topotecan
  • Topotecan Hydrochloride
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
Other Names:
  • Bortezomib
  • LDP-341
  • MLN341
  • PS-341

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. The Eastern Cooperative Oncology Group (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 * 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.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770731

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Daniel Karp, MD UT MD Anderson Cancer Center
  More Information

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

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00770731     History of Changes
Other Study ID Numbers: 2008-0425
Study First Received: October 9, 2008
Last Updated: February 12, 2013
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

Additional relevant MeSH terms:
Neoplasms
Sirolimus
Everolimus
Bortezomib
Topotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
 Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013