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

Sponsor:	Groupe D'Etude des Tumeurs Uro-Genitales
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00627354

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 ditartrate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized
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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Etoposide Mitoxantrone Mitoxantrone hydrochloride Vinorelbine Etoposide phosphate Vinorelbine tartrate

U.S. FDA Resources

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
Estimated Primary Completion Date:	September 2008 (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

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

Locations

France
Centre Regional Francois Baclesse	Recruiting
Caen, France, 14076
Contact: Florence Joly, MD, PhD 33-02-31-45-50-17 f.joly@baclesse.fr

Sponsors and Collaborators

Groupe D'Etude des Tumeurs Uro-Genitales

Investigators

Study Chair:

Florence Joly, MD, PhD

Centre Francois Baclesse

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000574184, GETUG- P02, INCA-RECF0422, EUDRACT-2006-001597-25
Study First Received:	February 29, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00627354 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV prostate cancer
recurrent prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vinblastine
Urogenital Neoplasms
Etoposide phosphate
Hormones
Neoplasms by Site
Sensory System Agents
Therapeutic Uses

Analgesics
Etoposide
Antineoplastic Agents, Hormonal
Mitosis Modulators
Antimitotic Agents
Genital Diseases, Male
Glucocorticoids
Pharmacologic Actions
Neoplasms
Vinorelbine
Tubulin Modulators
Mitoxantrone
Peripheral Nervous System Agents
Prostatic Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009