Overview

Sirolimus and Cetuximab in Advanced Malignancies

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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 combination will also be studied.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Cetuximab
Everolimus
Sirolimus
Criteria
Inclusion Criteria:

1. 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.

2. 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).

3. Eastern Cooperative Oncology Group (ECOG) performance status
4. Patients must have normal organ and marrow function defined as: absolute neutrophil
count >/= 1,000/mL; platelets >/=50,000/mL; creatinine (ULN); total bilirubin liver metastasis: total bilirubin 350 mg/dL; triglycerides
5. 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.

6. Patients with colorectal cancer with Kirsten rat sarcoma (kRAS) mutations (mutational
status must be available prior to entering the study)

7. Patients must be able to understand and be willing to sign a written informed consent
document.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, uncontrolled
infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.

2. Pregnant or lactating women.

3. History of hypersensitivity to cetuximab, murine products, or any component of the
formulation.

4. History of hypersensitivity to sirolimus.

5. History of hypersensitivity to any component of the formulation.

6. Patients with colorectal cancer with kRAS mutations. (mutational status must be
available prior to entering the study)

7. Patients unwilling or unable to sign informed consent document.