Prostate CancerPhase 2NCT00006114
Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase 2 study testing mitoxantrone hydrochloride and vinorelbine tartrate in people with Prostate Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 10 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- mitoxantrone hydrochloride and vinorelbine tartrate
- How many people
- Not given
- Where
- 10 sitesFrance
- Study dates
- May 1999to not given
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IV hormone refractory adenocarcinoma of the prostate
- Progressive disease despite hormonal therapy or orchiectomy
- No brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 9 g/dL
Hepatic:
- Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (unless bone metastasis)
- Bilirubin less than 2 times ULN
Renal:
- Creatinine less than 2 times ULN
Cardiovascular:
- Adequate cardiac function
Other:
- No other prior malignancy except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
- Prior corticosteroids allowed if started at least 8 weeks prior to study
Radiotherapy:
- At least 8 weeks since prior extensive radiotherapy
Surgery:
- See Disease Characteristics
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hopital Saint-Louis
Amiens, 80054 Cedex 1
Hopital Gouin
Clichy, 92110
Hopital Perpetuel Secours
Levallois-Perret, 92300
CHU de la Timone
Marseille, 13385
Hopital Laennec
Paris, 75007
Hopital Saint Antoine
Paris, 75571
Hopital Tenon
Paris, 75970
Polyclinique De Courlancy
Reims, F-51100
C.H. Senlis
Senlis, 60309
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
Toulon, 83056
About this study
Official title: First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate, progression free survival, overall survival, and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate.
- Determine the toxicities of this treatment regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 8. Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to treatment, prior to each course, and then at 2 months after study completion.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- mitoxantrone hydrochloride, vinorelbine tartrate
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitoxantrone hydrochlorideDrug
vinorelbine tartrateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 1999
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
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Louis Wendling, MD, Study chair, Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006114
- Sponsor's protocol ID
- CDR0000068126
- Other IDs
- FRE-GERCOR-NONA-U98-1, EU-20025
- Status last verified
- Sep 2000
- First submitted
- 3 Aug 2000
- Last updated
- 1 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine
- ClinicalTrials.gov ID
- NCT00006114
- Acronym / sponsor ID
- CDR0000068126
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- May 1999
- First posted
- 27 Jan 2003 (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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed description
OBJECTIVES:
- Determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate, progression free survival, overall survival, and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate.
- Determine the toxicities of this treatment regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 8. Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to treatment, prior to each course, and then at 2 months after study completion.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 80 years
- 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 |
|---|---|---|
| mitoxantrone hydrochloride | Drug | – |
| vinorelbine tartrate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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.
Jean-Louis Wendling, MD study chair
Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mitoxantrone hydrochloride and vinorelbine tartrate in people with Prostate Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 10 sites 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: status not confirmed, as of the sponsor's last update on 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
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.
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 1 Mar 2011.