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Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer (CABA-DOC)

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Taxotere

Jevtana

About this trial

This is an interventional other trial for Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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) ;

Sites / Locations

Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Do/Ca

Ca/Do

Arm Description

Arm Do/Ca : Taxotere 75mg/m2/3w x 4 cycles, followed by Jevtana 25mg/m2/3w x 4 cycles

Arm Ca/Do : Jevtana 25mg/m2/3w x 4 cycles, followed by Taxotere 75mg/m2/3w x 4 cycles

Outcomes

Primary Outcome Measures

Patient preference

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02044354

First Posted

January 22, 2014

Last Updated

August 7, 2017

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02044354

Brief Title

Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer

Acronym

CABA-DOC

Official Title

A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 22, 2014 (Actual)

Primary Completion Date

April 13, 2017 (Actual)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Castration-resistant Prostate Cancer

7. Study Design

Primary Purpose

Other

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

195 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Do/Ca

Arm Type

Other

Arm Description

Arm Do/Ca : Taxotere 75mg/m2/3w x 4 cycles, followed by Jevtana 25mg/m2/3w x 4 cycles

Arm Title

Ca/Do

Arm Type

Other

Arm Description

Arm Ca/Do : Jevtana 25mg/m2/3w x 4 cycles, followed by Taxotere 75mg/m2/3w x 4 cycles

Intervention Type

Drug

Intervention Name(s)

Taxotere

Intervention Type

Drug

Intervention Name(s)

Jevtana

Primary Outcome Measure Information:

Title

Patient preference

Description

Time Frame

Assessed up 21 weeks after randomization

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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) ;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karim Fizazi, MD, PhD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Study Chair

Facility Information:

Facility Name

Gustave Roussy

City

Villejuif

State/Province

Val de Marne

ZIP/Postal Code

94805

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

34789394

Citation

Baciarello G, Delva R, Gravis G, Tazi Y, Beuzeboc P, Gross-Goupil M, Bompas E, Joly F, Greilsamer C, Hon TNT, Barthelemy P, Culine S, Berdah JF, Deblock M, Ratta R, Flechon A, Cheneau C, Maillard A, Martineau G, Borget I, Fizazi K; Groupe d'Etude des Tumeurs Uro-Genitales (GETUG).. Patient Preference Between Cabazitaxel and Docetaxel for First-line Chemotherapy in Metastatic Castration-resistant Prostate Cancer: The CABADOC Trial. Eur Urol. 2022 Mar;81(3):234-240. doi: 10.1016/j.eururo.2021.10.016. Epub 2021 Nov 14.

Results Reference

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Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer

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