Prostate CancerPhase 2NCT00069888
A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
A Phase 2 study testing Docetaxel in people with Prostate Cancer, run by Sanofi at 1 site in United States.
Trial summary
This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. 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?
- Docetaxel
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Jan 2007
- 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
Who may be able to join
- patients with prostate cancer who have just undergone prostatectomy,
- high risk of their cancer recurring (High risk is defined as at least a 50 percent chance the cancer will return within three years after surgery.)
Who cannot join
- Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
- Prior radiation therapy
- Patients receiving any concurrent therapy for cancer. This includes alternative therapies
- Patients requiring concurrent treatment with corticosteroids, with the exception of inhaled and topical corticosteroids.
- History of a malignancy other than prostate cancer
- Peripheral neuropathy >/= Grade 2
- Psychological, familial, sociological or geographical conditions which do not permit treatment and/or medical follow-up required to comply with the study protocol
- Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients At High Risk of Relapse Following Prostatectomy
This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. During the trial, doctors will also closely monitor patients for side effects of the chemotherapy.
Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies. The researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor.
All of the study participants will receive up to 18 doses of docetaxel, each administered through a needle inserted into a vein. Each round of treatment will consist of 30-minute, weekly infusions for three consecutive weeks, followed by one week with no chemotherapy. Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that reduces the risk of an allergic reaction to the medication. If the side effects of the treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the trial.
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the preliminary effects of six cycles of adjuvant, weekly Taxotere® (three weeks on/one week off) on the rate of progression-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2003 (estimated)
- Study startNov 2001
- Primary completionJan 2007
- Study completionJan 2007
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.
- More trials run by SanofiThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yasir Nagarwala, M.D., Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069888
- Sponsor's protocol ID
- XRP6976J_2501
- Status last verified
- Jun 2011
- First submitted
- 2 Oct 2003
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients At High Risk of Relapse Following Prostatectomy
- ClinicalTrials.gov ID
- NCT00069888
- Acronym / sponsor ID
- XRP6976J_2501
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 6 Oct 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.
This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. During the trial, doctors will also closely monitor patients for side effects of the chemotherapy.
Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies. The researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor.
All of the study participants will receive up to 18 doses of docetaxel, each administered through a needle inserted into a vein. Each round of treatment will consist of 30-minute, weekly infusions for three consecutive weeks, followed by one week with no chemotherapy. Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that reduces the risk of an allergic reaction to the medication. If the side effects of the treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with prostate cancer who have just undergone prostatectomy,
- high risk of their cancer recurring (High risk is defined as at least a 50 percent chance the cancer will return within three years after surgery.)
Key exclusion criteria (8 listed)
- Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
- Prior radiation therapy
- Patients receiving any concurrent therapy for cancer. This includes alternative therapies
- Patients requiring concurrent treatment with corticosteroids, with the exception of inhaled and topical corticosteroids.
- History of a malignancy other than prostate cancer
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 |
|---|---|---|
| Docetaxel | Drug | – |
Primary outcome
To assess the preliminary effects of six cycles of adjuvant, weekly Taxotere® (three weeks on/one week off) on the rate of progression-free survival
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 8 Jun 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.
Yasir Nagarwala, M.D. study director
Sanofi
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 Docetaxel in people with Prostate Cancer, run by Sanofi at 1 site 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?
The sponsor lists 2 inclusion and 8 exclusion criteria. 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 8 Jun 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 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?
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?
To assess the preliminary effects of six cycles of adjuvant, weekly Taxotere® (three weeks on/one week off) on the rate of progression-free survival. 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 8 Jun 2011.