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A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen


Phase 3
18 Years
N/A
Not Enrolling
Male
Neoplasms, Prostatic Neoplasms

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Trial Information

A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen

Inclusion Criteria


Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate that is
refractory to hormone therapy and previously treated with a Taxotere®-containing
regimen.

2. Documented progression of disease (demonstrating at least one visceral or soft tissue
metastatic lesion, including a new lesion). Patients with non-measurable disease
must have documented rising prostate-specific antigen (PSA) levels or appearance of
new lesion.

3. Surgical or hormone-induced castration

4. Life expectancy > 2 months

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Exclusion criteria

1. Previous treatment with mitoxantrone

2. Previous treatment with <225 mg/m^2 cumulative dose of Taxotere (or docetaxel)

3. Prior radiotherapy to ≥ 40% of bone marrow

4. Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior
to enrollment in the study

5. Other prior malignancy, except for adequately treated superficial basal cell skin
cancer, or any other cancer from which the patient has been disease-free for less
than 5 years

6. Known brain or leptomeningeal involvement

7. Other concurrent serious illness or medical conditions

8. Inadequate organ function evidenced by unacceptable laboratory results

The investigator will evaluate whether there are other reasons why a patient may not
participate.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.

Outcome Time Frame:

From the date of randomization up to 104 weeks (study cut-off)

Safety Issue:

No

Principal Investigator

ICD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC6193

NCT ID:

NCT00417079

Start Date:

January 2007

Completion Date:

September 2009

Related Keywords:

  • Neoplasms
  • Prostatic Neoplasms
  • Cancer
  • Prostate
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Sanofi-Aventis USBridgewater, New Jersey  08807