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Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, October 2009
First Received: April 7, 2009   Last Updated: October 6, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00877773
  Purpose

The goal of this clinical research study is to learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of this drug will also be tested.


Condition Intervention Phase
Advanced Cancers
Drug: Temsirolimus
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tumor Response [ Time Frame: Baseline to Disease Progression (restaged at 8 weeks and at 4 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: April 2009
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Temsirolimus: Experimental Drug: Temsirolimus
25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least 3 months (unless temsirolimus is indicated as standard treatment for that disease).
  2. Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.
  3. Patients must have creatinine </= 3 X ULN; absolute neutrophil count >/= 1,000/mL; platelets >/= 50,000; bilirubin </= 3.0 gm/dL. Except for patients with liver metastases: total bilirubin </= 5 ULN.
  4. Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study.
  5. Patients must be off other anti-tumor agents for at least 5 half lives of the agent or 4 wks from the last day of treatment, whichever is shorter. For cytotoxic therapies, patients should be off treatment for 3 or more weeks.
  6. Patients may not be receiving any other experimental agents that are not FDA approved.
  7. Ability to understand and willingness to sign a written consent document.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Patients with creatinine clearance <10 mL/min
  3. Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
  4. Patients with major surgery within 30 days prior to entering study.
  5. Patients on inhibitors or inducers of CYP3A4 metabolism will have the inhibitors or inducers stopped unless clinically contraindicated. See section 6 (Concomitant Medications) and Appendix E of the protocol for details.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877773

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

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( Razelle Kurzrock, MD, BS / Professor )
Study ID Numbers: 2008-0827
Study First Received: April 7, 2009
Last Updated: October 6, 2009
ClinicalTrials.gov Identifier: NCT00877773     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced cancer
Advanced Cancer with genetic mutation
Phosphoinositides 3-kinase
PI3K
PIK3 mutations
Temsirolimus
CCI-779
Torisel
mTOR inhibitor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on February 04, 2010