PainPhase 2NCT00003781
Docetaxel in Treating Patients With Stage IV Prostate Cancer
A Phase 2 study testing docetaxel, pain therapy and quality-of-life assessment in people with Pain and Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site 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. PURPOSE: Phase II trial of docetaxel in treating patients who have stage IV prostate cancer that has not responded to hormone therapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Pain, Prostate Cancer
- What is being tested?
- docetaxel, pain therapy and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1998to Jun 2003
- 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 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV hormone refractory adenocarcinoma of the prostate Symptoms and evidence of disease progression despite standard hormonal therapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: At least 3 months Hematopoietic: WBC at least 3000/mm3 Neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT no greater than 2 times ULN (no greater than 1.5 times ULN if alkaline phosphatase is greater than 2.5 times ULN) Alkaline phosphatase no greater than 4 times ULN (no greater than 8 times ULN if known bone involvement and bilirubin and ALT in normal range) Renal: Not specified Other: At least 5 years since any prior malignancy except nonmelanoma skin cancer No other significant medical illness that would prevent compliance No hypersensitivity to drugs formulated with polysorbate-80 Must be able to complete written questionnaires and diaries
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 1 month since prior radiotherapy At least 2 months since prior strontium-89 Surgery: Not specified Other: At least one month since prior investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Phase II Study of Weekly Docetaxel (Taxotere) in Hormone Refractory Metastatic Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial of docetaxel in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
Read the detailed description
OBJECTIVES: I. Evaluate the efficacy of weekly docetaxel as measured by disease response, strength and duration of pain reduction, and either a decrease in analgesic use without an increase in pain, or a decrease in PSA, in patients with hormone refractory metastatic prostate cancer. II. Assess the efficacy of this regimen in terms of survival in this patient population. III. Evaluate the effect of this regimen on quality of life in these patients. IV. Determine qualitative and quantitative toxicities of this regimen in these patients.
OUTLINE: Patients receive docetaxel IV over 15-30 minutes weekly for 6 weeks. Courses repeat every 8 weeks. Therapy continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at weeks 1, 3, 5, and 7 of each course, and a daily pain medication diary is maintained during treatment. Patients are followed for 1 month or until resolution of toxicity, then every 3 months until death.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
- Conditions
- Pain, Prostate Cancer
- Being tested
- docetaxel, pain therapy, quality-of-life assessment
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, pain
- Medical subject headings
- Pain, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
pain therapyProcedure or surgery
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2004 (estimated)
- Study startDec 1998
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Beer, OHSU Knight Cancer Institute
- Investigators
- Tomasz Beer, MD, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003781
- Sponsor's protocol ID
- CDR0000066913
- Other IDs
- OHSU-5134, OCC-HOR-98037-L, RP-OHSU-5134, NCI-V99-1519
- Status last verified
- Apr 2017
- First submitted
- 1 Nov 1999
- Last updated
- 28 Apr 2017
- Results posted
- No
- 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 II Study of Weekly Docetaxel (Taxotere) in Hormone Refractory Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00003781
- Acronym / sponsor ID
- CDR0000066913
- Conditions
- Pain, Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- Dec 1998
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 22 Jul 2004 (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.
PURPOSE: Phase II trial of docetaxel in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
Detailed description
OBJECTIVES: I. Evaluate the efficacy of weekly docetaxel as measured by disease response, strength and duration of pain reduction, and either a decrease in analgesic use without an increase in pain, or a decrease in PSA, in patients with hormone refractory metastatic prostate cancer. II. Assess the efficacy of this regimen in terms of survival in this patient population. III. Evaluate the effect of this regimen on quality of life in these patients. IV. Determine qualitative and quantitative toxicities of this regimen in these patients.
OUTLINE: Patients receive docetaxel IV over 15-30 minutes weekly for 6 weeks. Courses repeat every 8 weeks. Therapy continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at weeks 1, 3, 5, and 7 of each course, and a daily pain medication diary is maintained during treatment. Patients are followed for 1 month or until resolution of toxicity, then every 3 months until death.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| docetaxel | Drug | – |
| pain therapy | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 28 Apr 2017.
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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 Beer, MD study chair
OHSU Knight Cancer Institute
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, pain therapy and quality-of-life assessment in people with Pain and Prostate Cancer, run by OHSU Knight Cancer Institute 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?
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 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.
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.