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

Prostate Cancer Clinical Trial

Official title:

Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627354
• Other study ID #: CDR0000574184
• Secondary ID: GETUG- P02INCA-R
• Status: Completed
• Phase: Phase 2
• First received: February 29, 2008
• Last updated: May 13, 2011
• Start date: September 2006

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• etoposide

• mitoxantrone hydrochloride

• prednisone

• vinorelbine tartrate

Locations

Country	Name	City	State
France	Centre Regional Francois Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Groupe D'Etude des Tumeurs Uro-Genitales

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palliative response rate			No
Secondary	Duration of palliative response			No
Secondary	Biological response			No
Secondary	Tumor response as assessed by RECIST criteria			No
Secondary	Time to progression			No
Secondary	Overall survival			No
Secondary	Quality of life as assessed by QLQ-PR25			No
Secondary	Impact on autonomy in patients > 70 years of age			No
Secondary	Toxicity			Yes