Prostate CancerPhase 2NCT00017563
Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
A Phase 2 study testing docetaxel, mitoxantrone hydrochloride and conventional surgery in people with Prostate Cancer, run by OHSU Knight Cancer Institute at 2 sites in United States.
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 and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- docetaxel, mitoxantrone hydrochloride and conventional surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2000to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- High-risk, as defined by 1 of the following:
- Stage T2b (palpable bilateral involvement) or surgically resectable T3
- PSA 15 ng/mL or greater
- Gleason grade greater than 4+3 (4+3, 4+4, or 5+any, but not 3+4)
- At least a 50% chance of prostate cancer recurrence within 5 years
- Planned prostatectomy as primary therapy
- No evidence of bone metastases by bone scan
- No evidence of lymph nodes greater than 2 cm on pelvic computed tomography (CT) scan (scan required only if PSA greater than 40 ng/mL)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Eastern Cooperative Oncology Group(ECOG) 0-2
Life expectancy:
- At least 10 years
Hematopoietic:
- White Blood Cell(WBC) at least 3,000/mm^3
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Conjugated bilirubin no greater than upper limit of normal (ULN)
- Alkaline phosphatase no greater than 4 times ULN
- Alanine transaminase(ALT) no greater than 2 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN)
Renal:
- Not specified
Cardiovascular:
- Ejection fraction greater than 50% by Multiple Gated Acquisition(MUGA)scan
Other:
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No significant active medical illness that would preclude study therapy
- No peripheral neuropathy grade 2 or greater
- No hypersensitivity to drugs formulated with polysorbate-80
- No significant contraindications to corticosteroids
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior cytotoxic chemotherapy
- No other concurrent cytotoxic chemotherapy
Endocrine therapy:
- No prior or concurrent conventional hormonal therapy
Radiotherapy:
- No prior or concurrent radiotherapy (external beam or brachytherapy)
Surgery:
- See Disease Characteristics
Other:
- No prior or concurrent cryotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
Portland VA Medical Center
Portland, Oregon, 97239
About this study
Official title: Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer
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 and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer.
Read the detailed description
OBJECTIVES:
- Determine the 5-year freedom from prostate-specific antigen (PSA) recurrence in patients treated with this regimen.
- Define the maximum tolerated dose of neoadjuvant docetaxel and mitoxantrone followed by prostatectomy in patients with high-risk localized prostate cancer. (Phase I completed as of 2/15/02)
- Determine the toxicity of this regimen in these patients.
- Determine the PSA response rate and pathologic response rate in patients treated with this regimen.
- Determine the clinical response in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the surgical margin status at time of prostatectomy in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of mitoxantrone. (Phase I completed as of 2/15/02)
Patients receive neoadjuvant docetaxel and mitoxantrone weekly on weeks 1-3. Treatment repeats once a week for a total of 4 courses.
Patients receive escalating doses of mitoxantrone until the maximum tolerated dose is determined. (Phase I completed as of 2/15/02)
Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel, mitoxantrone hydrochloride, conventional surgery
- Keywords
- adenocarcinoma of the prostate, stage II prostate cancer, stage III 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.
docetaxelDrug
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
mitoxantrone hydrochlorideDrug
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
conventional surgeryProcedure or surgery
Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel, Mitoxantrone, Conventional Surgery | Experimental | Drug: Docetaxel-35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: Mitoxantrone-Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
Procedure/Surgery: Conventional Surgery- Prostatectomy will be scheduled 2-4 weeks after the last dose of chemotherapy Receives: Drug: docetaxel; Drug: mitoxantrone hydrochloride; Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.
Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA > 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.
Measured: Every 3 months after surgery for up to 5 years.
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 startSep 2000
- Primary completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Tom Beer, OHSU Knight Cancer Institute
- Investigators
- Tomasz M. Beer, MD, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017563
- Sponsor's protocol ID
- CDR0000068719
- Other IDs
- OHSU-2794, OHSU-HOR-00037-L, NCI-G01-1962
- Status last verified
- Apr 2017
- First submitted
- 6 Jun 2001
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00017563
- Acronym / sponsor ID
- CDR0000068719
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2000
- Primary completion
- May 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 31 Aug 2011
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 and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer.
Detailed description
OBJECTIVES:
- Determine the 5-year freedom from prostate-specific antigen (PSA) recurrence in patients treated with this regimen.
- Define the maximum tolerated dose of neoadjuvant docetaxel and mitoxantrone followed by prostatectomy in patients with high-risk localized prostate cancer. (Phase I completed as of 2/15/02)
- Determine the toxicity of this regimen in these patients.
- Determine the PSA response rate and pathologic response rate in patients treated with this regimen.
- Determine the clinical response in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the surgical margin status at time of prostatectomy in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of mitoxantrone. (Phase I completed as of 2/15/02)
Patients receive neoadjuvant docetaxel and mitoxantrone weekly on weeks 1-3. Treatment repeats once a week for a total of 4 courses.
Patients receive escalating doses of mitoxantrone until the maximum tolerated dose is determined. (Phase I completed as of 2/15/02)
Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel, Mitoxantrone, Conventional Surgery | Experimental | Drug: docetaxel, Drug: mitoxantrone hydrochloride, Procedure: conventional surgeryDrug: Docetaxel-35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule. Drug: Mitoxantrone-Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks. Procedure/Surgery: Conventional Surgery- Prostatectomy will be scheduled 2-4 weeks after the last dose of chemotherapy |
Who may qualify
- Ages
- 18 to 120 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 |
|---|---|---|
| docetaxel35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule. | Drug | Docetaxel, Mitoxantrone, Conventional Surgery |
| mitoxantrone hydrochlorideInitial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks. | Drug | Docetaxel, Mitoxantrone, Conventional Surgery |
| conventional surgeryProstatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy. | Procedure or surgery | Docetaxel, Mitoxantrone, Conventional Surgery |
Primary outcome
Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.
Time frame: Every 3 months after surgery for up to 5 years.
Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA > 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tomasz M. Beer, MD study chair
OHSU Knight Cancer Institute
2 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 docetaxel, mitoxantrone hydrochloride and conventional surgery in people with Prostate Cancer, run by OHSU Knight Cancer Institute at 2 sites in United States.
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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence. (time frame: Every 3 months after surgery for up to 5 years.). 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 28 Apr 2017.