Doxil, Bevacizumab and Temsirolimus Trial
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00761644
First received: September 25, 2008
Last updated: May 29, 2013
Last verified: May 2013
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Purpose
The goal of this clinical research study is to learn the highest safe doses of the combination of Doxil (liposomal doxorubicin), Avastin (bevacizumab), and Torisel (Temsirolimus) that can be given to patients with advanced cancer that has spread or is unable to be surgically removed. The safety and effectiveness of this combination of drugs will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: Doxil Drug: Bevacizumab Drug: Temsirolimus |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Doxil, Bevacizumab and Temsirolimus |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Doxorubicin
Doxorubicin hydrochloride
Sirolimus
Everolimus
Temsirolimus
Bevacizumab
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum tolerated doses (MTDs) and Dose-limiting toxicities (DLTs) [ Time Frame: First cycle (21 days) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 206 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Doxil, Bevacizumab + Temsirolimus
Doxil day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours. Bevacizumab day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes. Temsirolimus days 1, 8 & 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes. |
Drug: Doxil
Day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours.
Other Names:
Drug: Bevacizumab
Day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes.
Other Names:
Drug: Temsirolimus
Days 1, 8 & 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with 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 three months.
- All patients must have an estimated life expectancy of at least 12 weeks.
- Patients must have measurable or evaluable disease
- Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- ECOG performance status </= 2 (Karnofsky >/= 60%).
- Patients must have organ and marrow function defined as: absolute neutrophil count >/= 1,500/mL; platelets >/=100,000/mL; creatinine </= 3 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 5 X ULN. In patients with significant liver disease and chronically elevated liver transaminases, ALT may be elevated as high as 8 X ULN.
- Cardiac ejection fraction >/= 50% without evidence of CHF
- 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, for the duration of study participation, and for 90 days after the last dose.
- 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 hormonal maintenance treatment for prostate cancer.
Exclusion Criteria:
- Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
- Poorly controlled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- Patients with clinically significant cardiovascular disease: - History of CVA within 6 months - Myocardial infarction or unstable angina within 6 months - Unstable angina pectoris - New York Heart Association Class CHF score ≥ II
- Prior cumulative doxorubicin dose > 300 mg/m2
- Pregnant or lactating women
- History of hypersensitivity to doxil, doxorubicin, HCL, temsirolimus or it's metabolites (including sirolimus), polysorbate 80, bevacizumab or murine products
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Patients < 12 years of age
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761644
Contacts
| Contact: Daniel Karp, MD | 713-563-1930 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| 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:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00761644 History of Changes |
| Other Study ID Numbers: | 2008-0384 |
| Study First Received: | September 25, 2008 |
| Last Updated: | May 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Metastatic cancer Doxil Liposomal doxorubicin Doxorubicin hydrochloride (liposomal) Avastin Bevacizumab Anti-VEGF monoclonal antibody |
rhuMAb-VEGF Torisel Temsirolimus CCI-779 Dynamic contrast-enhanced magnetic resonance imaging DCE-MRI scan |
Additional relevant MeSH terms:
|
Neoplasms Antibodies Antibodies, Monoclonal Sirolimus Everolimus Doxorubicin Bevacizumab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Anti-Bacterial Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013