CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)
- Conditions
- Prostatic Neoplasms
- Registration Number
- NCT01206036
- Lead Sponsor
- Central European Society for Anticancer Drug Research
- Brief Summary
In this Phase I study safety of the combination of Docetaxel and Temsirolimus needs to be shown before the study can be expanded into a Phase II study to examine the activity of a safe combination of Temsirolimus and Docetaxel in a comparison with Docetaxel alone.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method recommended dose 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 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.
- Secondary Outcome Measures
Name Time Method DPFS time 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.
quality of life 24 months Phase II Part: Quality of life using the EORTC questionnaire
safety as defined as occurence of treatment related adverse events 10 months Phase I Part: Secondary endpoint is the collection of safety data on the dose levels used in this part.
overall response 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.
PSA 24 months Phase II Part: Proportion of patients with drop of PSA of \> 30% in the evaluation period compared to baseline compared to baseline.
1-year Disease-Progression Free Survival Rate 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.
overall survival 24 months Phase II Part: overall survival (OS) measured from randomization until death or lost to follow up (censored survival time)
TTP-PSA 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 24 months Phase II Part: Evaluation of toxicity using CTCAE v4.0
Frequency of medication for pain 24 months Phase II Part: Frequency of medication for pain
Trial Locations
- Locations (1)
CESAR Study Center
🇩🇪Freiburg, Germany