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Prostatic NeoplasmsPhase 1/2CEPTASNCT01206036

CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)

A Phase 1/2 study testing Docetaxel and Temsirolimus in people with Prostatic Neoplasms, run by Central European Society for Anticancer Drug Research at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Docetaxel and Temsirolimus
How many people
19 participants
Where
2 sitesGermany
Study dates
Jul 2010to Oct 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult males ≥18 years of age.
  • Patients with CRPC defined as confirmed rise of PSA levels after orchiectomy or LHRH agonist based therapy.
  • Progressive disease, defined as PSA progression by confirmed rising PSA levels.
  • PSA at time of study entry ≥2ng/ml within 1 week prior to treatment (according to Scher 2008).
  • Bone metastasis and/or lymph node and/or visceral organ metastases allowed. Measurable and non measurable disease allowed.
  • Performance status (PS) 0-1 ECOG.
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  • Signed written informed consent.
  • White blood cell count (WBC) ≥4x10^9/L with neutrophils ≥1.5x10^9/L, platelet count ≥100x10^9/L, hemoglobin ≥9g/dL.
  • Total bilirubin <=2 x upper limit of normal.
  • AST and ALT <=2.5 x upper limit of normal, or <=5 x upper limit of normal in case of liver metastases.
  • Serum creatinine <=1.5 x upper limit of normal or creatinine clearance > 60 ml/min.
  • Androgen ablation will have to be continued. Antiandrogens such as bicalutamide will have to be discontinued at least 4 weeks prior to the start of study treatment.
  • Adult males ≥ 18 years of age.
  • Patients with CRPC defined as confirmed rise of PSA levels after orchiectomy or LHRH agonist based therapy
  • Progressive disease, defined as PSA progression by confirmed rising PSA levels
  • PSA at time of study entry ≥ 2ng/ml within 1 week prior to treatment (according to Scher 2008).
  • Bone metastasis and/or lymph node and/or visceral organ metastases allowed. Measurable and non measurable disease allowed.
  • Performance status (PS) 0-1 ECOG.
  • Signed written informed consent.
  • White blood cell count (WBC) ≥4x10^9/L with neutrophils ≥1.5x10^9/L, platelet count ≥100x10^9/L, hemoglobin ≥9g/dL.
  • Total bilirubin <= 2 x upper limit of normal.
  • AST and ALT <=2.5 x upper limit of normal, or <=5 x upper limit of normal in case of liver metastases.
  • Serum creatinine <=1.5 x upper limit of normal or creatinine clearance >60 ml/min.
  • Androgen ablation will have to be continued. Antiandrogens such as bicalutamide will have to be discontinued at least 4 weeks prior to the start of study treatment.
  • Completed 8 cycles (up to 26 weeks) treatment in Arm A
  • White blood cell count (WBC) ≥4x10^9/L with neutrophils ≥1.5x10^9/L, platelet count ≥100x10^9/L, hemoglobin ≥9g/dL.
  • Total bilirubin <=2 x upper limit of normal.
  • AST and ALT <=2.5 x upper limit of normal, or <=5 x upper limit of normal in case of liver metastases.
  • Serum creatinine <=1.5 x upper limit of normal or creatinine clearance >60 ml/min.
  • General condition sufficient to allow therapy with temsirolimus.
  • Signed Informed Consent.

Who cannot join

  • Clinically symptomatic brain or meningeal metastasis.
  • Receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers.
  • Any investigational drug within the 30 days before inclusion.
  • Not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy, as judged by the investigator.
  • Nonhealing wound or ulcer.
  • Grade ≥ 3 hemorrhage within the past month.
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  • Any condition / concomitant disease not allowing chemotherapy with docetaxel, prednisone and temsirolimus in the discretion of the treating physician, like: Renal insufficiency requiring dialyses; congestive heart failure or uncontrolled angina pectoris; prior myocardial infarction within 6 months of start of chemotherapy; uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of ≥ 3 anti-hypertensive drugs) or arrhythmias; instable diabetes mellitus, ulceration from diabetes mellitus or other conditions not allowing high dose corticosteroids; effusions in pericardium, pleura or abdomen symptomatic and in need of being punctured.
  • Known hypersensitivity to any of the components in the temsirolimus infusion or other medical reasons for not being able to receive adequate premedication (antihistamine agents).
  • Legal incapacity or limited legal capacity
  • Medical or psychological conditions that would not permit the patient to
  • complete the study or sign informed consent.
  • Prior Chemotherapy.
  • Clinically symptomatic brain or meningeal metastasis.
  • Receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers.
  • Any investigational drug within the 30 days before inclusion.
  • Not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy, as judged by the investigator.
  • Nonhealing wound or ulcer.
  • Grade ≥ 3 hemorrhage within the past month.
  • Any condition / concomitant disease not allowing chemotherapy with docetaxel, prednisone and temsirolimus in the discretion of the treating physician, like: Renal insufficiency requiring dialyses; congestive heart failure or uncontrolled angina pectoris; prior myocardial infarction within 6 months of start of chemotherapy; uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of ≥ 3 anti-hypertensive drugs) or arrhythmias; instable diabetes mellitus, ulceration from diabetes mellitus or other conditions not allowing high dose corticosteroids; effusions in pericardium, pleura or abdomen symptomatic and in need of being punctured.
  • Known hypersensitivity to any of the components in the temsirolimus infusion or other medical reasons for not being able to receive adequate premedication (antihistamine agents).
  • Legal incapacity or limited legal capacity.
  • Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
  • Disease Progression in the first 8 cycles (up to 26 weeks).

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • CESAR Study Center

    Essen

  • CESAR Study Center

    Freiburg im Breisgau

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Docetaxel, Temsirolimus
Keywords
castration, prostate cancer, castration resistant prostate cancer, PSA, Docetaxel, Temsirolimus, disease progression free survival, DPFS, dose escalation
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere

    DL 1: Docetaxel 60mg/m^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15.

  • TemsirolimusDrug

    Also called Torisel

    DL 1: Docetaxel 60mg/m^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recommended dose

    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.

    Measured: 10 months

  2. disease progression-free survival

    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.

    Measured: 24 months

Secondary outcomes (10)

  1. safety as defined as occurence of treatment related adverse events

    Phase I Part: Secondary endpoint is the collection of safety data on the dose levels used in this part.

    Measured: 10 months

  2. overall response

    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.

    Measured: 24 months

  3. 1-year Disease-Progression Free Survival Rate

    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.

    Measured: 24 months

  4. DPFS time

    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.

    Measured: 24 months

  5. TTP-PSA

    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)†"

    Measured: 24 months

  6. toxicity based on treatment-related toxicities using CTCAE v4.0

    Phase II Part: Evaluation of toxicity using CTCAE v4.0

    Measured: 24 months

  7. PSA

    Phase II Part: Proportion of patients with drop of PSA of > 30% in the evaluation period compared to baseline compared to baseline.

    Measured: 24 months

  8. quality of life

    Phase II Part: Quality of life using the EORTC questionnaire

    Measured: 24 months

  9. overall survival

    Phase II Part: overall survival (OS) measured from randomization until death or lost to follow up (censored survival time)

    Measured: 24 months

  10. Frequency of medication for pain

    Phase II Part: Frequency of medication for pain

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionSep 2014
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01206036
Sponsor's protocol ID
C-II-007
Other IDs
2010-018370-21
Acronym
CEPTAS
Status last verified
Jan 2016
First submitted
17 Aug 2010
Last updated
27 Jan 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Docetaxel and Temsirolimus in people with Prostatic Neoplasms, run by Central European Society for Anticancer Drug Research at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recommended dose (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01206036.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.

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