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.
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.
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.
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.
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
quality of life 24 months Phase II Part: Quality of life using the EORTC questionnaire
Trial Locations
- Locations (1)
CESAR Study Center
🇩🇪Freiburg, Germany
CESAR Study Center🇩🇪Freiburg, Germany