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SWITCH: Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT01576029
Collaborator
(none)
2
Enrollment
8
Locations
2
Arms
16
Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:
  • To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels.
Secondary Objectives:

  • PSA response rate

  • Overall survival (OS)

  • Incidence of Adverse Events

Condition or Disease Intervention/Treatment Phase
  • Drug: CABAZITAXEL (XRP6258)
  • Drug: DOCETAXEL (XRP6976)
 Phase 2

Detailed Description

Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Docetaxel

75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks

Drug: DOCETAXEL (XRP6976)
Pharmaceutical form: solution Route of administration: intravenous
Experimental: Cabazitaxel

25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks

Drug: CABAZITAXEL (XRP6258)
Pharmaceutical form: solution Route of administration: intravenous

Outcome Measures

Primary Outcome Measures

  1. Median time to PSA progression [up to 60 days]

Secondary Outcome Measures

  1. PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA [up to 60 days]

  2. Overall Survival: Median time elapsed between the date of starting treatment until death by any cause [up to a maximum of 2 years]

  3. Number of patients with adverse events [up to a maximum of 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion criteria :

  • Documentation of histological prostate cancer;

  • Patients with metastatic CRPC (Castration-Resistant Metastatic Prostate Cancer) who progressed with hormone deprivation, including the withdrawal of antiandrogen-class drugs for at least 4 weeks, and 6 weeks for bicalutamide or if documented that PSA did not decrease during 3 months of this therapy;

  • Documentation of metastasis by imaging (computerized tomography [CT], magnetic resonance imaging [MRI] or bone scan), in patients with PSA < 20 ng/mL at the time of inclusion

  • Provide minor PSA response (characterized by a reduction between 1% and 49%) or increase up to 24% in PSA levels, in relation to the value measured before starting docetaxel therapy, measured at least 7 days after the fourth cycle of docetaxel;

  • Patient has received 4 cycles of docetaxel at a dose of 75 mg/m2 ;

  • ECOG performance status of 0 or 1;

  • Marrow, liver and renal function within acceptable values;

  • PSA ≥ 2 ng/mL;

  • Testosterone level ≤ 50 ng/dL (for patients with no prior history of orchiectomy).

Exclusion criteria:

  • Prior use of chemotherapy, except for docetaxel for four cycles;

  • Documented disease progression during treatment with docetaxel (first 4 cycles);

  • Patients with metastases resulting in neurological damage;

  • Inability to continue receiving gonadotropin-releasing hormone agonists in patients with no prior history of orchiectomy;

  • Use of recombinant methionyl human granulocyte-colony stimulating factor non-glycosylated (G-CSF) in the 24 hours preceding baseline;

  • Any other current neoplasia or over the past 5 years, except for basal cell skin carcinoma or squamous skin cell carcinoma;

  • Known seropositivity for HIV (Human immunodeficiency Virus );

  • Concomitant diseases, such as significant neurological or psychiatric disease; uncontrolled hypercalcemia or any other serious comorbidity;

  • Hypersensitivity or allergy to any of the study treatments.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigational Site Number 004 Barretos Brazil 14780-480
2 Investigational Site Number 008 Brasília Brazil 70390-150
3 Investigational Site Number 009 Londrina Brazil 86015-520
4 Investigational Site Number 003 Mogi das Cruzes Brazil 0830-500
5 Investigational Site Number 005 Porto Alegre Brazil 90840-440
6 Investigational Site Number 006 Rio De Janeiro Brazil 20231-050
7 Investigational Site Number 001 Rio De Janeiro Brazil 22260-020
8 Investigational Site Number 007 São Paulo Brazil 01246-000

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT01576029
Other Study ID Numbers:
  • CABAZ_L_05933
  • U1111-1119-8381
First Posted:
Apr 12, 2012
Last Update Posted:
Dec 24, 2013
Last Verified:
Dec 1, 2013
Additional relevant MeSH terms:
Prostatic Neoplasms
Docetaxel

Study Results

No Results Posted as of Dec 24, 2013