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An Multicenter, Randomized Study of Comparison of Docetaxel Plus Prednisone With Mitoxantrone Plus Prednisone in the Patients With Hormone-refractory (Androgen-independent) Metastatic Prostate Cancer


Phase 3
N/A
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

Trial Information

An Multicenter, Randomized Study of Comparison of Docetaxel Plus Prednisone With Mitoxantrone Plus Prednisone in the Patients With Hormone-refractory (Androgen-independent) Metastatic Prostate Cancer


Inclusion Criteria:



- Histologically or cytologically proven prostate adenocarcinoma

- Androgen independent prostate Cancer S/P orchiectomy and/or LHRH agonist Testosterone
< 50 ng/dl (ie 1.735 nmol/l)

- Documented progressive disease

- Patients should have achieved stable analgesia for 7 days

- Karnofsky Performance Status ≥ 70

- No prior treatment with cytotoxic agent (except estramustine)

- Normal cardiac function must be confirmed by Left ventricular ejection fraction

- Adequate organ function:

1. Hematology:

- Neutrophils > 1.5 x 10^9/L

- Hemoglobin > 10 g/dl. Erythropoietin use is allowed, but red blood cell
transfusion to upgrade the hemoglobin level is not allowed

- Platelets > 100 x 10^9/L

2. Hepatic function:

- Total bilirubin < the upper-normal limit of the institution.

- Alanine aminotransferase and Aspartate transaminase < 1.5 times the
upper-normal limit of the institution.

3. Renal function:

- Creatinine < 1.5 times the upper normal limit (ie National Cancer
Institution grade < 1)

- No brain or leptomeningeal metastases

Exclusion Criteria:

- Prior radiotherapy to >25% of bone marrow (whole pelvic irradiation is not allowed)

- prior cytotoxic chemotherapy, except monotherapy with estramustine

- prior isotope therapy

- history of another cancer within the preceding five year

- symptomatic peripheral neuropathy grade ≥ 2

- other serious illness or medical condition:

1. Congestive heart failure even if controlled. Previous history of myocardial
infarction or angina pectoris within 1 year from study entry, uncontrolled
hypertension or uncontrolled arrhythmias.

2. Active uncontrolled infection

3. Peptic ulcer, unstable diabetes mellitus or other contraindications for the use
of corticosteroids.

4. Auto-immune disease (lupus, sclerodermia, rheumatoid polyarthritis)

- treatment with any other anti-cancer therapy

- treatment with bisphosphonates

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy: Overall survival

Outcome Time Frame:

From beginning to end of the study

Safety Issue:

No

Principal Investigator

Jing Fu

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

China: Food and Drug Administration

Study ID:

DOCET_L_01833

NCT ID:

NCT00436839

Start Date:

January 2007

Completion Date:

June 2012

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

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