Prostate CancerPhase 2NCT00627354
Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase 2 study testing etoposide, mitoxantrone hydrochloride and prednisone in people with Prostate Cancer, run by Groupe D'Etude des Tumeurs Uro-Genitales at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- etoposide, mitoxantrone hydrochloride and prednisone
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- etoposide, mitoxantrone hydrochloride, prednisone, vinorelbine tartrate
- Keywords
- stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoposideDrug
mitoxantrone hydrochlorideDrug
prednisoneDrug
vinorelbine tartrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Palliative response rate
Secondary outcomes (8)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startSep 2006
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe D'Etude des Tumeurs Uro-Genitales
- Sponsor type
- University, hospital or other
- Investigators
- Florence Joly, MD, PhD, Study chair, Centre Francois Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627354
- Sponsor's protocol ID
- CDR0000574184
- Other IDs
- GETUG- P02, INCA-RECF0422, EUDRACT-2006-001597-25
- Status last verified
- Jul 2009
- First submitted
- 29 Feb 2008
- Last updated
- 16 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00627354
- Acronym / sponsor ID
- CDR0000574184
- Conditions
- Prostate Cancer
- Keywords
- stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Groupe D'Etude des Tumeurs Uro-GenitalesUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2011 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etoposide | Drug | – |
| mitoxantrone hydrochloride | Drug | – |
| prednisone | Drug | – |
| vinorelbine tartrate | Drug | – |
Primary outcome
Palliative response rate
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Joly, MD, PhD study chair
Centre Francois Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing etoposide, mitoxantrone hydrochloride and prednisone in people with Prostate Cancer, run by Groupe D'Etude des Tumeurs Uro-Genitales at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palliative response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2011.