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

Sponsor

Groupe D'Etude des Tumeurs Uro-Genitales (Other)

Overall Status

Completed

CT.gov ID

NCT00627354

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2006

Actual Primary Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

Palliative response rate []

Secondary Outcome Measures

Duration of palliative response []
Biological response []
Tumor response as assessed by RECIST criteria []
Time to progression []
Overall survival []
Quality of life as assessed by QLQ-PR25 []
Impact on autonomy in patients > 70 years of age []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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