Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627354
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : May 16, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which drug is more effective in killing tumor cells.

PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to etoposide or vinorelbine works as second-line therapy in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: etoposide Drug: mitoxantrone hydrochloride Drug: prednisone Drug: vinorelbine tartrate Phase 2

Detailed Description:



  • Determine the palliative response rate in patients with hormone-resistant prostate cancer treated with mitoxantrone hydrochloride vs etoposide vs vinorelbine ditartrate as second-line therapy.


  • Determine the duration of palliative response in patients treated with these regimens.
  • Determine the biological response (PSA > 50%) in these patients.
  • Determine the time to progression (biological and clinical) in these patients.
  • Determine the overall survival of these patients.
  • Determine the quality of life and the impact on autonomy of patients over 70 years of age.
  • Determine the toxicity of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive mitoxantrone hydrochloride IV over 5 minutes once a week for 3 weeks.
  • Arm II: Patients receive oral etoposide twice daily on days 1-14.
  • Arm III: Patients receive oral vinorelbine ditartrate once daily on days 1 and 8 and oral prednisone once daily on days 1-21.

Treatment in all three arms repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer
Study Start Date : September 2006
Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Palliative response rate

Secondary Outcome Measures :
  1. Duration of palliative response
  2. Biological response
  3. Tumor response as assessed by RECIST criteria
  4. Time to progression
  5. Overall survival
  6. Quality of life as assessed by QLQ-PR25
  7. Impact on autonomy in patients > 70 years of age
  8. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic progressive disease meeting the following criteria:

      • Increase in measurable lesions > 25%
      • Increase in bone lesions > 25%
      • Biological progression rate of PSA > 4 ng/mL
  • Received docetaxel as first-line chemotherapy
  • Received at least 1 prior regimen of hormone therapy
  • Pain > 2 on Visual Analog Scale or continuing level 2 analgesics
  • No symptomatic or evolutionary CNS disease


  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times normal
  • Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
  • Transaminases ≤ 1.5 times normal
  • Bilirubin ≤ 1.5 times normal
  • No prior malignancy except basal cell skin cancer
  • No peripheral neuropathy or severe neuropathy ≥ grade 2
  • No other severe lung, hepatic, renal, or digestive disease that would be complicated by treatment
  • LVEF > 50%
  • No history of peptic ulcer, unstable diabetes, or other contraindication to using steroids
  • No severe infection requiring antibiotics


  • See Disease Characteristics
  • More than 8 weeks since prior metabolic radiotherapy
  • More than 4 weeks since prior external radiotherapy
  • At least 1 month since prior docetaxel-based chemotherapy
  • At least 1 month since prior antiandrogen therapy in the case of complete hormonal blockage
  • No participation in another clinical trial within the past 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00627354

Centre Regional Francois Baclesse
Caen, France, 14076
Sponsors and Collaborators
Groupe D'Etude des Tumeurs Uro-Genitales
Study Chair: Florence Joly, MD, PhD Centre Francois Baclesse Identifier: NCT00627354     History of Changes
Other Study ID Numbers: CDR0000574184
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
recurrent prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Etoposide phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents