CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS) (CEPTAS)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study With Temsirolimus Versus no add-on in Patients With Castration Resistant Prostate Cancer (CRPC) Receiving First-line Docetaxel Chemotherapy|
- recommended dose [ Time Frame: 10 months ]Phase I Part: Primary endpoint is the Recommended Dose (RD) for the Phase II Part chosen between the three DLs based on the dose escalation scheme.
- disease progression-free survival [ Time Frame: 24 months ]Phase II Part: Primary endpoint is to evaluate the activity of the addition of Temsirolimus to standard treatment on the disease progression-free survival (DPFS Chemotherapy) in patients with castration resistant prostate cancer receiving first-line Docetaxel chemotherapy.
- safety as defined as occurence of treatment related adverse events [ Time Frame: 10 months ]Phase I Part: Secondary endpoint is the collection of safety data on the dose levels used in this part.
- overall response [ Time Frame: 24 months ]Phase II Part: Responses of measurable disease (RECIST 1.1 criteria) including the overall response rate (RR, CFR+PR) and the disease control rate (PR+CR+SD). In addition to the overall response rate RR, the trial will also evaluate the number of responders based on PSA evaluation only (RR-PSA) and the number of responders based on RECIST evaluation only (RR-RECIST) among those who are evaluable by that criterion, respectively. RR is only evaluated for the chemotherapy part of the Phase II part of the trial.
- 1-year Disease-Progression Free Survival Rate [ Time Frame: 24 months ]Phase II Part: 1-year Disease-Progression Free Survival Rate (DPFS-1yR); defined as the quotient defined exactly in the same way as DPFS-6mR with the landmark time point equal to 1 year, +/- 4 weeks for assessment one year after randomization.
- DPFS time [ Time Frame: 24 months ]Phase II Part: DPFS time measured as failure time between 1st randomization and disease progression or death whatever occurred first. Patients lost-to follow-up, dropping out (e.g. when withdrawing consent) or patients surviving progression free at the end-of-study time point are treated as censored cases.
- TTP-PSA [ Time Frame: 24 months ]Phase II Part: Time to PSA progression (TTP-PSA) measured from randomization until PSA progression as defined in Scher et al. "Decline from baseline: record time from start of therapy to first PSA increase that is ≥ 25% and ≥ 2 ng/mL above the nadir, and which is confirmed by a second value 3 or more weeks later (ie, a confirmed rising trend)†"
- toxicity based on treatment-related toxicities using CTCAE v4.0 [ Time Frame: 24 months ]Phase II Part: Evaluation of toxicity using CTCAE v4.0
- PSA [ Time Frame: 24 months ]Phase II Part: Proportion of patients with drop of PSA of > 30% in the evaluation period compared to baseline compared to baseline.
- quality of life [ Time Frame: 24 months ]Phase II Part: Quality of life using the EORTC questionnaire
- overall survival [ Time Frame: 24 months ]Phase II Part: overall survival (OS) measured from randomization until death or lost to follow up (censored survival time)
- Frequency of medication for pain [ Time Frame: 24 months ]Phase II Part: Frequency of medication for pain
|Study Start Date:||July 2010|
|Study Completion Date:||October 2015|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
The purpose of this Phase I study is to evaluate feasibility of dose levels DL1, DL2 and DL3 (which are combinations of Temsirolimus and Docetaxel) and defining a recommended dose (RD) for the Phase II part using these dose levels in a dose escalating scheme.
Secondary objectives are the collection of safety data on the dose levels used in this part.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206036
|CESAR Study Center|
|CESAR Study Center|
|Study Chair:||Rudolf Morant, MD||Tumor-und Brustzentrum ZeTuP, St. Gallen, Switzerland|