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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00627354
First received: February 29, 2008
Last updated: May 13, 2011
Last verified: July 2009
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: etoposide
Drug: mitoxantrone hydrochloride
Drug: prednisone
Drug: vinorelbine tartrate
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Palliative response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of palliative response [ Designated as safety issue: No ]
  • Biological response [ Designated as safety issue: No ]
  • Tumor response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life as assessed by QLQ-PR25 [ Designated as safety issue: No ]
  • Impact on autonomy in patients > 70 years of age [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: September 2006
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627354

Locations
France
Centre Regional Francois Baclesse
Caen, France, 14076
Sponsors and Collaborators
Groupe D'Etude des Tumeurs Uro-Genitales
Investigators
Study Chair: Florence Joly, MD, PhD Centre Francois Baclesse
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00627354     History of Changes
Other Study ID Numbers: CDR0000574184, GETUG- P02, INCA-RECF0422, EUDRACT-2006-001597-25
Study First Received: February 29, 2008
Last Updated: May 13, 2011
Health Authority: United States: Federal Government

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Etoposide
Etoposide phosphate
Mitoxantrone
Vinorelbine
Analgesics
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014