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

NCT01206036 | Completed Phase 1

• 2 other identifiers: C-II-0072010-018370-21
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostatic Neoplasms

Keywords

castration; prostate cancer; castration resistant prostate cancer; PSA; Docetaxel; Temsirolimus; disease progression free survival; DPFS; dose escalation

Outcome Measures

Primary Outcomes (2)

• 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.

  10 months

• 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.

  24 months

Secondary Outcomes (10)

• safety as defined as occurence of treatment related adverse events

  10 months

• overall response

  24 months

• 1-year Disease-Progression Free Survival Rate

  24 months

• DPFS time

  24 months

• TTP-PSA

  24 months

Interventions

Docetaxel DRUG

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.

Also known as: Taxotere

Temsirolimus DRUG

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.

Also known as: Torisel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Clinically symptomatic brain or meningeal metastasis.
• Receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers.
• 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.
• 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.

Sponsors & Collaborators

• Central European Society for Anticancer Drug Research: lead

Study Sites (2)

CESAR Study Center

Essen, Germany

Location

CESAR Study Center

Freiburg im Breisgau, Germany

Location

Related Links

• web page of CESAR (Central European Society for Anticancer Drug Research-EEIG)

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; temsirolimus

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Rudolf Morant, MD

  Tumor-und Brustzentrum ZeTuP, St. Gallen, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: September 21, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

DE (2)