Prostate CancerPhase 1/2NCT00115635
Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
A Phase 1/2 study testing docetaxel and gemcitabine in people with Prostate Cancer, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to determine the optimal dose of the combination of docetaxel and gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with respect to efficacy and toxicity in a phase II trial. Read more about this study
- Who is it for?
- Ages 18 to 95 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- docetaxel and gemcitabine
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2005to Jul 2007
- Phase
- Phase 1/2
- 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 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified adenocarcinoma of the prostate.
- Hormone refractory prostate cancer (HRPC) defined as progression during previous anti-hormone treatment. Patients must have been off previous anti-androgen therapy for more than 4 weeks.
- Stage IV disease (verified by imaging or clinical examination).
- PSA > 10 microgram/l.
- PSA progression defined as a > 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment.
- Castrate level of testosterone (< 50 ng).
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- No previous oestrogen or steroid as metastatic prostate cancer treatment.
- Satisfactory hepatic function in the form of total bilirubin ≤ UNL (upper normal limit), ASAT/ALAT ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL.
- Satisfactory renal function, defined as serum creatinine ≤ 1.5 x UNL.
- Satisfactory haematologic function defined as ANC >1.5 x 10^9/l, leucocytes >3.0 x 10^9/l, thrombocytes ≥ 100 x 10^9/l, haemoglobin > 7 mmol/l
- ECOG performance status ≤ 2.
- Life expectancy > 3 months.
- Patient must be able to adhere to protocol requirements.
- Written informed consent.
- > 18 years of age.
Who cannot join
- Previous prostate cancer treatment with oestrogens or steroid hormones.
- Previous chemotherapy.
- Previous treatment with systemic radioactive isotopes.
- Bisphosphonate treatment (concomitant).
- Radiation therapy covering more than 25% of the bone marrow producing area.
- Other serious coincidental and/or concomitant medical condition.
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- Symptomatic cerebral metastases.
- Other previous or current malignant disease, excluding *adequately treated and cured planocellular skin carcinoma; or *other cancer assessed to carry minimal risk of recurrence.
- ECOG performance status > 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
The aim of the study is to determine the optimal dose of the combination of docetaxel and gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with respect to efficacy and toxicity in a phase II trial.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel, gemcitabine
- Keywords
- Hormonal refractory, chemotherapy, docetaxel, gemcitabine
- 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
gemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate-specific antigen (PSA) response
Secondary outcomes (3)
Clinical response
Time to PSA progression
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2005 (estimated)
- Study startMar 2005
- Study completionJul 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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Eli Lilly and Company
- Investigators
- Lisa Sengelov, MD, Principal investigator, Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115635
- Sponsor's protocol ID
- UR0416
- Other IDs
- EudraCT number: 2004-002353-31
- Status last verified
- Oct 2007
- First submitted
- 23 Jun 2005
- Last updated
- 2 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00115635
- Acronym / sponsor ID
- UR0416
- Conditions
- Prostate Cancer
- Keywords
- Hormonal refractory, chemotherapy, docetaxel, gemcitabine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Sanofi, Eli Lilly and Company
- Study start
- Mar 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 24 Jun 2005 (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.
The aim of the study is to determine the optimal dose of the combination of docetaxel and gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with respect to efficacy and toxicity in a phase II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically verified adenocarcinoma of the prostate.
- Hormone refractory prostate cancer (HRPC) defined as progression during previous anti-hormone treatment. Patients must have been off previous anti-androgen therapy for more than 4 weeks.
- Stage IV disease (verified by imaging or clinical examination).
- PSA > 10 microgram/l.
- PSA progression defined as a > 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment.
Key exclusion criteria (9 listed)
- Previous prostate cancer treatment with oestrogens or steroid hormones.
- Previous chemotherapy.
- Previous treatment with systemic radioactive isotopes.
- Bisphosphonate treatment (concomitant).
- Radiation therapy covering more than 25% of the bone marrow producing area.
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 | – |
| gemcitabine | Drug | – |
Primary outcome
Prostate-specific antigen (PSA) response
3 secondary outcomes
Clinical response
Time to PSA progression
Toxicity
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 2 Oct 2007.
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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.
Lisa Sengelov, MD principal investigator
Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing docetaxel and gemcitabine in people with Prostate Cancer, run by Herlev Hospital at 1 site in Denmark.
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 15 inclusion and 9 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 2 Oct 2007. 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 Denmark. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Prostate-specific antigen (PSA) response. 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 2 Oct 2007.