CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS) (CEPTAS)
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|ClinicalTrials.gov Identifier: NCT01206036|
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : January 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Docetaxel Drug: Temsirolimus||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||October 2015|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206036
|CESAR Study Center|
|CESAR Study Center|
|Study Chair:||Rudolf Morant, MD||Tumor-und Brustzentrum ZeTuP, St. Gallen, Switzerland|