CABA-DOC: Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Do/Ca Arm Do/Ca : Taxotere 75mg/m2/3w x 4 cycles, followed by Jevtana 25mg/m2/3w x 4 cycles |
Drug: Taxotere
Drug: Jevtana
|
| Other: Ca/Do Arm Ca/Do : Jevtana 25mg/m2/3w x 4 cycles, followed by Taxotere 75mg/m2/3w x 4 cycles |
Drug: Taxotere
Drug: Jevtana
|
Outcome Measures
Primary Outcome Measures
- Patient preference [Assessed up 21 weeks after randomization]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Affiliated to a social security regimen ;
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Male patients older than 18 years ;
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Histologically confirmed adenocarcinoma of the prostate ;
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Continued androgen deprivation therapy either by LHRH agonists/antagonists or orchidectomy ;
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Serum testosterone <0.50 ng/ml (1.7 nmol/L) ;
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Progressive disease (PSA progression or radiological progression or clinical progression) ;
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ECOG 0-2 ;
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Information delivered to patient and informed consent form signed by the patient or his legal representative ;
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Adequate organ or bone marrow function as evidenced by:
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Hemoglobin >/= 10 g/dL
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Absolute neutrophil count >/=1.5 x 109/L,
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Platelet count >/=100 x 109/L,
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AST/SGOT and/or ALT/SGPT </=1.5 x ULN;
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Total bilirubin </=1.5 x ULN,
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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:
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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 ;
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Prior treatment with Taxotere or Jevtana ;
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Pre-existing symptomatic peripheral neuropathy grade > 2 (CTCAE V4) ;
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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 ;
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History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs ;
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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 ;
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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) ;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gustave Roussy | Villejuif | Val de Marne | France | 94805 |
Sponsors and Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Sanofi
Investigators
- Study Chair: Karim Fizazi, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013-004243-22
- 2013/2072