All tumor types which do not have standard treatment options and who might benefit from taxane containing chemotherapy
Conditions
Interventions
Subjects will be randomized in a 1:1 ratio to receive CriPec® docetaxel in cycle 1 and Taxotere® in cycle 2 (Arm A) or Taxotere® in cycle 1 and CriPec® docetaxel in cycle 2 (Arm B). Both CriPec® doce
Sponsors
Erasmus MC, Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: • Age ≥ 18 years at signing of Informed Consent Form (ICF). • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. • Estimated life expectancy of at least 12 weeks. • Ability and willingness to give written informed consent and to comply with the requirements of the study. • Patients with pathologically confirmed diagnosis of advanced, recurrent and progressive cancer with measurable disease according to RECIST 1.1 [Appendix 3] of a histological type that are refractory to standard therapy or for whom no standard therapy exists and where treatment with a taxane is an appropriate treatment option. This includes, but is not limited to, oesophageal, stomach, prostate, bladder, breast, head and neck, ovarian and non-small cell lung cancer. • Willing to undergo repeated tumor biopsies
Exclusion criteria
Exclusion criteria: • Less than 4 weeks since the last treatment of chemotherapy, biological therapy, immunotherapy or systemic radiotherapy (except palliative radiation delivered to 1.5 x the Upper Limit of Normal (ULN) for the institution if no liver metastases (> 2 x ULN in patients with liver metastases). • AST or ALT > 2.5 x ULN if no liver metastases (> 5x ULN in patients with liver metastases). • Hepatitis B surface antigen or hepatitis C positivity in combination with abnormal liver function tests if it is indicated to be determined by the Investigator. Medical history of: • Non-alcoholic steatohepatitis (NASH). • History of human immunodeficiency virus (HIV) antibody positive or use of antiretroviral therapy. • Alcoholic and autoimmune hepatitis. • Ischemic hepatitis, Cardiovascular dysfunction or impaired liver oxygenation (e.g. due to hypotension or right heart failure). • Any type of skin disease for which systemic corticosteroids is mandatory. Inadequate renal function as evidenced by any of the following: • Serum creatinine > 1.5 x ULN. • Estimated Glomerular Filtration Rate of < 50 mL/min/1.73m2 calculated by Modification of Diet in Renal Disease (MDRD) formula or creatinine clearance of < 50 mL/min calculated by Cockcroft-Gault. Clinically significant (i.e. active) cardiovascular disease as evidenced by any of the following: • Stroke within 6 months prior to Cycle 1 Day 1. • Transient Ischemic Attack (TIA) within 6 months prior to Cycle 1 Day 1. • Myocardial infarction within 6 months prior to Cycle 1 Day 1. • Unstable angina. • New York Heart Association (NYHA) Grade II or greater Congestive Heart Failure at screening [The Criteria Committee of the New York Heart Association 1994]. • Serious cardiac arrhythmia requiring medication. Other: • Patients who are pregnant or breastfeeding; serum pregnancy test will be made before start of each cycle • Absence of effective means of contraception on Cycle 1 Day 1 in female patients of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) or in male patients who are not surgically sterile and who have female partners of childbearing potential. • Major surgical procedure (including open biopsy and excluding central line intraveno
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Plasma levels of total and released (free) docetaxel after dosing; Cmax, Tmax, AUClast, AUCinf, Thalf, Cl and Vss in relation to body weight (kg). Incidence of grade 3 or 4 adverse events (AEs) during the first cycle of CriPec® docetaxel or Taxotere®. | — |
Primary
| Measure | Time frame |
|---|---|
| The difference in concentration of docetaxel in tumor tissue after administration of CriPec® docetaxel compared to Taxotere®. | — |
Contacts
Public ContactF. Atrafi
Erasmus MC, Cancer Institute, Doctor Molewaterplein 40, 3015 GD Rotterdam
Outcome results
None listed