Status:
COMPLETED
Sirolimus and Cetuximab in Advanced Malignancies
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of sirolimus and cetuximab that can be given to patients with advanced cancer. The safety of this drug...
Detailed Description
The Study Drugs: Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking protein on the surface of the cancer cell, called the epidermal growth factor receptor (EGFR). S...
Eligibility Criteria
Inclusion
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
- Patients must be \>/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment providing radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be \>/= 5 half-lives or \>/= 3 weeks form the last dose (whichever comes first).
- Eastern Cooperative Oncology Group (ECOG) performance status \</= 3.
- Patients must have normal organ and marrow function defined as: absolute neutrophil count \>/= 1,000/mL; platelets \>/=50,000/mL; creatinine \</= 3 X upper limit of normal (ULN); total bilirubin \</= 2.0; ALT(SGPT) \</= 5 X ULN; Exception for patients with liver metastasis: total bilirubin \</= 3 x ULN; ALT(SGPT) \</= 8 X ULN; cholesterol \</= 350 mg/dL; triglycerides \</= 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, for the duration of study participation, and for 30 days after the last dose.
- Patients with colorectal cancer with Kirsten rat sarcoma (kRAS) mutations (mutational status must be available prior to entering the study)
- Patients must be able to understand and be willing to sign a written informed consent document.
Exclusion
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
- Pregnant or lactating women.
- History of hypersensitivity to cetuximab, murine products, or any component of the formulation.
- History of hypersensitivity to sirolimus.
- History of hypersensitivity to any component of the formulation.
- Patients with colorectal cancer with kRAS mutations. (mutational status must be available prior to entering the study)
- Patients unwilling or unable to sign informed consent document.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00940381
Start Date
July 1 2009
End Date
May 1 2014
Last Update
November 18 2015
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030