Prostate CancerPhase 2NCT00587431
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
A Phase 2 study testing GnRh (Leuprolide), Testosterone Gel and Docetaxel in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal. 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?
- GnRh (Leuprolide), Testosterone Gel and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Feb 2008
- 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
- Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.
- Patient must have a serum testosterone > 180 ng/dl.
- Karnofsky performance status (KPS)>_70%.
- Patients must have adequate organ function as defined by the following
- laboratory criteria:
- WBC >_ 3500/mm3
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- ANC >_1500/mm3
- Platelet count >100,000/mm3
- Hemoglobin >8.0g/dL
- Creatinine <1.6mg/dl
- Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL)
- SGOT and SGPT If alkaline phosphatase is _< 2.5 x ULN, any elevations in
- AST/ALT; OR if AST/ALT is _<1.5 x ULN, any elevation in alkaline phos
- Prior hormonal therapy is allowed as:
- Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy).
- One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy).
- Patients must be at least 18 years of age.
- Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment
Who cannot join
- Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
- Uncontrolled serious active infection.
- Anticipated survival of less than 3 months.
- Active CNS or epiduraltumor
- Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
- Peripheral neuropathy >_ grade 3.
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- Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.
- Prior chemotherapy
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.
- Conditions
- Prostate Cancer
- Being tested
- GnRh (Leuprolide), Testosterone Gel, Docetaxel
- Keywords
- Prostate, Cancer, Docetaxel, 03-076
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRh (Leuprolide)Drug
Also called 22.5 mg intramuscular injection
Leuprolide LUPRON
Testosterone GelDrug
Also called AndroGel
Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)
DocetaxelDrug
Also called Taxotere
70 mg/m2 given on day o1 of each 3 week cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: GnRh (Leuprolide); Drug: Testosterone Gel; Drug: Docetaxel |
| 2 | Active comparator | Not described Receives: Drug: GnRh (Leuprolide); Drug: Testosterone Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy
Measured: Conclusion of the study (at 6 months then at 18 months post-treatment)
Secondary outcomes (1)
The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.
Docetaxel Pharmacokinetic parameters for cycles 1 and 2.
Measured: at Cycle 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJul 2003
- Primary completionFeb 2008
- Study completionFeb 2008
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 Memorial Sloan Kettering Cancer CenterThe 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Rathkopf, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587431
- Sponsor's protocol ID
- 03-076
- Status last verified
- Oct 2023
- First submitted
- 21 Dec 2007
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00587431
- Acronym / sponsor ID
- 03-076
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Docetaxel, 03-076
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 21 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GnRh (Leuprolide), Drug: Testosterone Gel, Drug: Docetaxel |
| 2 | Active comparator | Drug: GnRh (Leuprolide), Drug: Testosterone Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.
- Patient must have a serum testosterone > 180 ng/dl.
- Karnofsky performance status (KPS)>_70%.
- Patients must have adequate organ function as defined by the following
- laboratory criteria:
Key exclusion criteria (10 listed)
- Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
- Uncontrolled serious active infection.
- Anticipated survival of less than 3 months.
- Active CNS or epiduraltumor
- Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
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 |
|---|---|---|
| GnRh (Leuprolide)Also: 22.5 mg intramuscular injectionLeuprolide LUPRON | Drug | 1, 2 |
| Testosterone GelAlso: AndroGelStarting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p) | Drug | 1, 2 |
| DocetaxelAlso: Taxotere70 mg/m2 given on day o1 of each 3 week cycle | Drug | 1 |
Primary outcome
PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy
Time frame: Conclusion of the study (at 6 months then at 18 months post-treatment)
1 secondary outcome
The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.
Time frame: at Cycle 1 and 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- 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.
Dana Rathkopf, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 GnRh (Leuprolide), Testosterone Gel and Docetaxel in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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 18 inclusion and 10 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 7 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2014). 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?
PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy (time frame: Conclusion of the study (at 6 months then at 18 months post-treatment)). 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 7 Nov 2023.