a. Locally advanced or metastatic non-small cell lung cancer. b. Locally advanced or metastatic epithelial ovarian carcinoma. c. Locally advanced or metastatic adenocarcinoma of the pancreas. d. Locally advanced or metastatic bladder cancer. e. Locally advanced or metastatic, inoperable breast cancer, as combination therapy with paclitaxel, when anthracyclines are ineffective or contraindicated.
Conditions
Interventions
Administration of a microdose (100 ug) of gemcitabine
Sponsors
Antoni van Leeuwenhoek hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 years. 2. Indication for treatment with gemcitabine. 3. Histologically or cytologically confirmed diagnosis of: a. Locally advanced or metastatic non-small cell lung cancer. b. Locally advanced or metastatic epithelial ovarian carcinoma. c. Malign mesothelioma 4. Able and willing to give written informed consent. 5. WHO performance status of 0 or 1. 6. Able and willing to undergo blood sampling for PK analysis. 7. All toxicities related to prior treatment should have resolved to CTCAE grade 1 or less. 8. Willing and able to comply with study restrictions and to remain at the study center for the required duration . 9. Adequate organ system function.
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for study entry if any of the following criteria are met: 1. Prior chemotherapy, radiotherapy, radio immunotherapy, or immunotherapy within 7 days of the first dose of study treatment 2. Known hypersensitivity to gemcitabine. 3. Presence of known brain metastases or active central nervous system (CNS) disease. 4. Prior treatment with gemcitabine within 30 days of the first dose. 5. New York Heart Association Class 3 or 4 heart disease, active ischemia, or any uncontrolled, unstable cardiac condition for which treatment for the condition is indicated but is not controlled despite adequate therapy, including angina pectoris, cardiac arrhythmia, hypertension, congestive heart failure or myocardial infarction within the previous 26 weeks. 6. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study. 7. Active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment. 8. Pregnant or lactating. 9. Known positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HC Ab) or has a known positive test result for human immunodeficiency virus (HIV) or a history of HIV disease. 10. Serious medical or psychiatric condition that, in the opinion of the Investigator, should preclude the patient from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters will be the concentration of gemcitabine in patient plasma. Pharmacokinetic parameters will be calculated from the acquired data. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Determination of plasma concentrations with LC-MS/MS. - Investigate the intracellular effect of gemcitabine after administration of a microdose and after administration of a therapeutic dosage. | — |
Contacts
Public ContactS. Marchetti
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Clinical Pharmacology Department of Medical Oncology Plesmanlaan 121
Outcome results
None listed