Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients
This study has been terminated.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: April 7, 2009
Last updated: July 8, 2014
Last verified: July 2014
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.
- Patients must have creatinine </= 3 X upper limit of normal (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.
- 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.
- 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.
- Patients may not be receiving any other experimental agents that are not FDA approved.
- Ability to understand and willingness to sign a written consent document.
- Treatment on this study may begin within 24 hours after Phase 0 dose of Temsirolimus.
- Pregnant or lactating women.
- Patients with creatinine clearance <10 mL/min
- Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
- Patients with major surgery within 30 days prior to entering study.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877773
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Daniel Karp, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 7, 2009
||July 8, 2014
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer with genetic mutation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 20, 2014
Physiological Effects of Drugs