Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer
Overview[ - collapse ][ - ]
Purpose | Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have different toxicity profiles. Many patients who are receiving Jevtana for second-line treatment indicate they prefer this agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than Taxotere in first-line setting. The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. Despite similar PFS improvements over placebo in phase III trials, results clearly showed that patients preferred pazopanib over sunitinib. A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in first-line setting with overall survival as a primary end-point. Assessing patient preference between Jevtana and Taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future. Assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane. |
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Condition | Metastatic Castration-resistant Prostate Cancer |
Intervention | Drug: Taxotere Drug: Jevtana |
Phase | Phase 3 |
Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
Responsible Party | Gustave Roussy, Cancer Campus, Grand Paris |
ClinicalTrials.gov Identifier | NCT02044354 |
First Received | January 22, 2014 |
Last Updated | January 24, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | January 22, 2014 |
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Last Updated Date | January 24, 2014 |
Start Date | January 2014 |
Estimated Primary Completion Date | February 2016 |
Current Primary Outcome Measures | Patient preference [Time Frame: Assessed up 21 weeks after randomization] [Designated as safety issue: No]Patient preference (Taxotere versus Jevtana) assessed by a single question after completion of the second period of chemotherapy. Primary outcome measure will be assessed in the intent-to-treat population as defined by all patients having completed the first 4 cycles without progression and having received at least 1 cycle of the second treatment period. Patients having progressed during the first period will discontinue the trial. |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer |
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Official Title | A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer |
Brief Summary | Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have different toxicity profiles. Many patients who are receiving Jevtana for second-line treatment indicate they prefer this agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than Taxotere in first-line setting. The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. Despite similar PFS improvements over placebo in phase III trials, results clearly showed that patients preferred pazopanib over sunitinib. A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in first-line setting with overall survival as a primary end-point. Assessing patient preference between Jevtana and Taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future. Assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label |
Condition | Metastatic Castration-resistant Prostate Cancer |
Intervention | Drug: Taxotere Drug: Jevtana |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 174 |
Estimated Completion Date | February 2016 |
Estimated Primary Completion Date | January 2016 |
Eligibility Criteria | Inclusion Criteria: - Affiliated to a social security regimen ; - Male patients older than 18 years ; - Histologically confirmed adenocarcinoma of the prostate ; - Continued androgen deprivation therapy either by LHRH agonists/antagonists or orchidectomy ; - Serum testosterone <0.50 ng/ml (1.7 nmol/L) ; - Progressive disease (PSA progression or radiological progression or clinical progression) ; - ECOG 0-2 ; - Information delivered to patient and informed consent form signed by the patient or his legal representative ; - Adequate organ or bone marrow function as evidenced by: - Hemoglobin >/= 10 g/dL - Absolute neutrophil count >/=1.5 x 109/L, - Platelet count >/=100 x 109/L, - AST/SGOT and/or ALT/SGPT =1.5 x ULN; - Total bilirubin =1.5 x ULN, - Serum creatinine =1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded Exclusion Criteria: - Patients having received an investigational drug and/or prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior enrolment in the study, excepted radiotherapy directed to a single bone lesions which is nonacceptable if within 2 weeks ; - Prior treatment with Taxotere or Jevtana ; - Pre-existing symptomatic peripheral neuropathy grade > 2 (CTCAE V4) ; - Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed ; - History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs ; - Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus), active infection including HIV infection, active Hepatitis B or C infection that would preclude participation in the trial ; - Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) ; |
Gender | Male |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Karim Fizazi, MD, PhD 0142116264 karim.fizazi@gustaveroussy.fr |
Location Countries | France |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02044354 |
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Other Study ID Numbers | 2013-004243-22 |
Has Data Monitoring Committee | No |
Information Provided By | Gustave Roussy, Cancer Campus, Grand Paris |
Study Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
Collaborators | Sanofi |
Investigators | Study Chair: Karim Fizazi, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Gustave Roussy | Villejuif, Val de Marne, France, 94805 Contact: Karim Fizazi, MD, PhD | 0142116264+33 | karim.fizazi@gustaveroussy.frPrincipal Investigator: Karim Fizazi, MD, PhD Recruiting |
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