Prostate CancerPhase 2NCT00482274
Docetaxel in Treating Patients With Relapsed Prostate Cancer
A Phase 2 study testing docetaxel in people with Prostate Cancer, run by OHSU Knight Cancer Institute at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer. 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
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Jul 2009
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate.
- Prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy.
- Serum PSA > 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir PSA >0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if prior to 8 months.
- Serum testosterone < 50 ng/ml.
- No evidence of metastases on bone scan.
- No evidence of metastases on CT scan of the abdomen and pelvis.
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- ECOG performance status < 2.
- Laboratory criteria for entry: absolute neutrophil count ≥ 1.2 K/cu mm, platelets ≥ 100 K/cu mm, serum bilirubin ≤ upper limit of normal (ULN), SGOT and SGPT ≤ 1.5 times institutional ULN if alkaline phosphatase ≤ ULN, alkaline phosphatase ≤ 5 times ULN if SGOT and SGPT are ≤ ULN, a serum creatinine ≤ 2 times institutional ULN.
- Signed informed consent.
Who cannot join
- A second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer.
- Life expectancy < 3 months.
- Grade 2 or higher peripheral neuropathy.
- Prior investigational agent within the past 28 days.
- Less than a 10% decrease (or continued rise) in PSA in response to initial androgen-deprivation therapy.
- More than 12 months since initiation of androgen-deprivation therapy.
- Prior docetaxel chemotherapy.
- Patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. Patients on stable doses of systemic corticosteroids will be eligible.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043
About this study
Official title: Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.
Secondary
- Determine the time to PSA recurrence in patients receiving this treatment.
- Determine the time to metastatic disease in patients receiving this treatment.
- Determine the time to androgen independent state in patients receiving this treatment.
- Determine the time to death from any cause in patients receiving this treatment.
OUTLINE: This is an open label study.
Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study therapy, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV 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
Also called Taxotere
Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml
Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.
Measured: While receiving study treatment (approximately 6 months)
Secondary outcomes (4)
Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)
Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.
Measured: Average days to develop recurrence from treatment start date amount applicable participants
Time to Metastatic Disease
Due to the limited enrollment, this analysis was not completed.
Measured: Measured at Time of documented metastases (no historical estimate is available)
Time to Androgen Independent State
Due to the limited enrollment, this analysis was not completed.
Measured: Measured at date of documented androgen independence (no estimate available)
Time to Death From Any Cause
Due to the limited enrollment, this analysis was not completed.
Measured: measured at date of death (no estimate available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Drug supplier stopped funding due to loss of study drug (docetaxel) patent.
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
- 3 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, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482274
- Sponsor's protocol ID
- CDR0000546975
- Other IDs
- P30CA069533, OHSU-2838, OHSU-SOL-06076-LM
- Status last verified
- Apr 2017
- First submitted
- 4 Jun 2007
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
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 II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy.
- ClinicalTrials.gov ID
- NCT00482274
- Acronym / sponsor ID
- CDR0000546975
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug supplier stopped funding due to loss of study drug (docetaxel) patent.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 5 Jun 2007 (estimated)
- Results
- Posted 24 Aug 2010
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 docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.
Secondary
- Determine the time to PSA recurrence in patients receiving this treatment.
- Determine the time to metastatic disease in patients receiving this treatment.
- Determine the time to androgen independent state in patients receiving this treatment.
- Determine the time to death from any cause in patients receiving this treatment.
OUTLINE: This is an open label study.
Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study therapy, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (9 listed)
- Histologically confirmed adenocarcinoma of the prostate.
- Prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy.
- Serum PSA > 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir PSA >0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if prior to 8 months.
- Serum testosterone < 50 ng/ml.
- No evidence of metastases on bone scan.
Key exclusion criteria (8 listed)
- A second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer.
- Life expectancy < 3 months.
- Grade 2 or higher peripheral neuropathy.
- Prior investigational agent within the past 28 days.
- Less than a 10% decrease (or continued rise) in PSA in response to initial androgen-deprivation therapy.
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 |
|---|---|---|
| docetaxelAlso: TaxotereDocetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle. | Drug | – |
Primary outcome
Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml
Time frame: While receiving study treatment (approximately 6 months)
Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.
4 secondary outcomes
Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)
Time frame: Average days to develop recurrence from treatment start date amount applicable participants
Time to Metastatic Disease
Time frame: Measured at Time of documented metastases (no historical estimate is available)
Time to Androgen Independent State
Time frame: Measured at date of documented androgen independence (no estimate available)
Time to Death From Any Cause
Time frame: measured at date of death (no estimate available)
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 principal investigator
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 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?
The sponsor lists 9 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: stopped early, 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 24 Aug 2010). 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 a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml (time frame: While receiving study treatment (approximately 6 months)). 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.