Overview

Lapatinib With Sirolimus or Metformin

Status:
Completed

Trial end date:
2015-09-01

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to find the highest tolerable dose of 2 different combinations of drugs that can be given to patients with advanced cancer. The first combination of drugs is Tykerb (lapatinib) and Rapamune (sirolimus), and the second combination is lapatinib and Glucophage (metformin). The safety of these drug combinations will also be studied.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Everolimus
Lapatinib
Metformin
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 at least 3 weeks beyond their previous cytotoxic treatment. Patient
must wait at least 5 half-lives or 3 weeks, whichever is shorter, from their previous
targeted or biologic therapy; In addition, patients must be at least 3 weeks beyond
the last session of radiation therapy or major surgery. Local palliative radiation
therapy that is not delivered to all target lesions is allowed immediately before or
during treatment.

3. Eastern Cooperative Oncology Group (ECOG) performance status should be less or equal
to 3

4. Patients must have normal organ and marrow function defined as: absolute neutrophil
count (ANC) >/= 750/mL; platelets >/= 50,000/mL; creatinine normal (ULN) for the Sirolimus Arm and creatinine < 1.5 mg/dl for the Metformin arm;
total bilirubin 2 could
will be allowed on study if the hyperbilirubinemia is believed to be secondary only to
the Gilbert syndrome); ALT (SGPT) metastasis: total bilirubin
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 must be able to understand and be willing to sign a written informed consent
document

7. Patients with treated brain metastases are allowed in both arms of the study.

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 Lapatinib or any component of the formulation.

4. Patients who have malabsorption syndrome

5. Patients with class III or IV congestive heart failure as defined by New York Heart
Association functional classification system

6. Patients unwilling or unable to sign informed consent document

7. History of hypersensitivity to Sirolimus or any component of the formulation (for
Lapatinib and Sirolimus arm only)

8. History of hypersensitivity to metformin or any component of the formulation (for
Lapatinib and Metformin arm only)