Overview

Everolimus and Capecitabine in Patients With Advanced Malignancy

Status:
Unknown status
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
Summary
In the investigators study the investigators combine everolimus, administrated twice daily at a fixed total dose of 10 mg continuously with capecitabine administered bid for 14 days followed by 7 days rest. In this study, capecitabine will be dose escalated.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Treatments:
Capecitabine
Everolimus
Sirolimus
Criteria
Inclusion Criteria:

- Patients with histological or cytological confirmed malignancies

- Measurable lesion according to RECIST criteria (only for the phase II part of the
study)

- ECOG / WHO performance status of 0-2

- Age ≥ 18 years

- Life expectancy of at least 3 months

- Minimal acceptable safety laboratory values defined as:

- WBC ≥ 3.0 x 109 /L

- Platelet count ≥ 100 x 109 /L

- Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALT or AST ≤ 2.5 x ULN, in
case of liver metastases ≤ 5 x ULN

- Renal function as defined by creatinine < 150μmol/L

- Able and willing to give written informed consent

- Able to swallow and retain oral medication

- Able and willing to undergo blood sampling for pharmacokinetic and pharmacogenetic
analysis

- Mentally, physically and geographically able to undergo treatment and follow up.

Exclusion Criteria:

- Patients with known alcoholism, drug addiction and/or psychotic disorders in the
history that are not suitable for adequate follow up

- Women who are pregnant or breast feeding

- Women of childbearing potential who refuse to use a reliable contraceptive method
throughout the study

- Serious concomitant systemic disorder that would compromise the safety of the patient,
at the discretion of the investigator

- Any other medical condition that would interfere with study procedures and/or decrease
safety of the protocol treatment