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Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer

G

Gustave Roussy

Status and phase

Terminated
Phase 2

Conditions

Prostate Cancer

Treatments

Drug: docetaxel and samarium

Study type

Interventional

Funder types

Other

Identifiers

NCT00126230
TAX-SAMAR

Details and patient eligibility

About

This is a prospective phase II trial of docetaxel-samarium in patients with hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine.

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients older than 18 years and less than 80 years
  • Histologically-proven adenocarcinoma of the prostate
  • Evidence of bone metastases and progressive, hormone-refractory, disease
  • No previous chemotherapy
  • No previous radiotherapy, except radiotherapy directed to the prostate and/or to a single bony lesion
  • No previous carcinoma, except basal-cell carcinoma of the skin
  • Adequate renal function: measured or calculated creatinine clearance > 60 ml/min
  • Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
  • Signed informed consent.

Exclusion criteria

  • Patients infected by the Human Immunodeficiency Virus (HIV)
  • Patients who do not fit inclusion criteria

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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