Prostate CancerPhase 2NCT00260611
Study of Oxaliplatin and Taxotere in Prostate Cancer
A Phase 2 study testing Oxaliplatin and Taxotere in people with Prostate Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
The primary objective for this study is to evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy. The secondary objectives are to compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety). 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?
- Oxaliplatin and Taxotere
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Sep 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
- Must have histologically or cytologically confirmed adenocarcinoma consistent clinically and histologically with carcinoma of the prostate Confirmed androgen independent prostate cancer (progression despite castrate levels of serum testosterone) Measurable or evaluable disease (PSA elevation will constitute evaluable disease) 18 years of age. Because no dosing or adverse event data are currently available on the use of oxaliplatin in patients < 18 years of age, they are excluded from this study.
- Life expectancy of greater than 3 months. ECOG Performance status of 0-1. No more than 2 prior regimens of cytotoxic chemotherapy. Androgen deprivation (castration or LHRH analogue), and prior antiandrogens allowed.
- Patients must be off bicalutamide or nilutamide > 42 days, megestrol or flutamide > 28 days.
- Concurrent bisphosphonate therapy allowed. Patients with prior radiotherapy for treatment of their bony metastases will be included if time since radiation is > 4 weeks, and if PSA is clearly rising.
- Patients must have acceptable organ function as defined as: :WBC > 2500/mm3 or ANC > 1500/mm3, hemoglobin > 9.0 g/dL, platelet count > 100,000/mm3; Bilirubin < 1.5 mg/dL, SGOT/SGPT < 2 x ULN (< 4 x ULN if liver metastases present), PT/PTT normal; Creatinine < 1.8 mg/dL Adequate neurologic function defined as no clinically significant peripheral neuropathy, defined as any neuropathy ≤ grade 1.
- Adequate cardiovascular function defined as no active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months.
Who cannot join
- No other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment. May not be taking other investigational drugs while on trial.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- No prior therapy with oxaliplatin is allowed. No history of allergic reactions attributed to the drugs used in this study or compounds of similar chemical or biologic composition.
- No history of intolerance or allergy to the antiemetics to be administered in conjunction with the study drugs (i.e., 5 HT3 antagonists).
- No concurrent other active cancer from another primary site, except squamous cell and basal cell carcinoma of the skin.
- No other serious concomitant illness will be allowed, including interstitial pneumonia, extensive and symptomatic fibrosis of the lung, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, NYHA Class III or IV, serious cardiac arrhythmia, uncontrolled diabetes mellitus or active infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Study of Oxaliplatin and Taxotere in Androgen Independent Prostate Cancer
The primary objective for this study is to evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy. The secondary objectives are to compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety).
Read the detailed description
This is a single institution phase II study of oxaliplatin and Taxotere in patients with androgen independent prostate cancer previously treated with up to two cytotoxic chemotherapy regimens. During this study, the efficacy and safety of this combination will be evaluated. The primary objective for this study is to evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy. The secondary objectives are to compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety). There will be up to 35 male subjects >= 18 years of age enrolled on this single institution study.
- Conditions
- Prostate Cancer
- Being tested
- Oxaliplatin, Taxotere
- Keywords
- prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called eloxatin
TaxotereDrug
Also called Docefrez, Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin and Taxotere | Experimental | Patients will receive both docetaxel and oxaliplatin, IV on day 1 of each cycle. Treatment will be repeated every 21 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or >50% increase in serum PSA. Receives: Drug: Oxaliplatin; Drug: Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy.
Subjects once off treatment wil be followed for survival
Measured: Followed for survival
Secondary outcomes (1)
To compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety).
Subjects will be followed for survival
Measured: Follow for survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startNov 2004
- Primary completionSep 2007
- Study completionSep 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 University of PittsburghThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Leonard J Appleman, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260611
- Sponsor's protocol ID
- 04-011
- Status last verified
- Mar 2015
- First submitted
- 29 Nov 2005
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Oxaliplatin and Taxotere in Androgen Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00260611
- Acronym / sponsor ID
- 04-011
- Conditions
- Prostate Cancer
- Keywords
- prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Nov 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 1 Dec 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 primary objective for this study is to evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy. The secondary objectives are to compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety).
Detailed description
This is a single institution phase II study of oxaliplatin and Taxotere in patients with androgen independent prostate cancer previously treated with up to two cytotoxic chemotherapy regimens. During this study, the efficacy and safety of this combination will be evaluated. The primary objective for this study is to evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy. The secondary objectives are to compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety). There will be up to 35 male subjects >= 18 years of age enrolled on this single institution study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin and Taxotere | Experimental | Drug: Oxaliplatin, Drug: TaxoterePatients will receive both docetaxel and oxaliplatin, IV on day 1 of each cycle. Treatment will be repeated every 21 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or >50% increase in serum PSA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have histologically or cytologically confirmed adenocarcinoma consistent clinically and histologically with carcinoma of the prostate Confirmed androgen independent prostate cancer (progression despite castrate levels of serum testosterone) Measurable or evaluable disease (PSA elevation will constitute evaluable disease) 18 years of age. Because no dosing or adverse event data are currently available on the use of oxaliplatin in patients < 18 years of age, they are excluded from this study.
- Life expectancy of greater than 3 months. ECOG Performance status of 0-1. No more than 2 prior regimens of cytotoxic chemotherapy. Androgen deprivation (castration or LHRH analogue), and prior antiandrogens allowed.
- Patients must be off bicalutamide or nilutamide > 42 days, megestrol or flutamide > 28 days.
- Concurrent bisphosphonate therapy allowed. Patients with prior radiotherapy for treatment of their bony metastases will be included if time since radiation is > 4 weeks, and if PSA is clearly rising.
- Patients must have acceptable organ function as defined as: :WBC > 2500/mm3 or ANC > 1500/mm3, hemoglobin > 9.0 g/dL, platelet count > 100,000/mm3; Bilirubin < 1.5 mg/dL, SGOT/SGPT < 2 x ULN (< 4 x ULN if liver metastases present), PT/PTT normal; Creatinine < 1.8 mg/dL Adequate neurologic function defined as no clinically significant peripheral neuropathy, defined as any neuropathy ≤ grade 1.
Key exclusion criteria (6 listed)
- No other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment. May not be taking other investigational drugs while on trial.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- No prior therapy with oxaliplatin is allowed. No history of allergic reactions attributed to the drugs used in this study or compounds of similar chemical or biologic composition.
- No history of intolerance or allergy to the antiemetics to be administered in conjunction with the study drugs (i.e., 5 HT3 antagonists).
- No concurrent other active cancer from another primary site, except squamous cell and basal cell carcinoma of the skin.
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 |
|---|---|---|
| OxaliplatinAlso: eloxatin | Drug | Oxaliplatin and Taxotere |
| TaxotereAlso: Docefrez, Docetaxel | Drug | Oxaliplatin and Taxotere |
Primary outcome
To evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy.
Time frame: Followed for survival
Subjects once off treatment wil be followed for survival
1 secondary outcome
To compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety).
Time frame: Follow for 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 25 Mar 2015.
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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.
Leonard J Appleman, MD principal investigator
University of Pittsburgh Medical 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 Oxaliplatin and Taxotere in people with Prostate Cancer, run by University of Pittsburgh 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 6 inclusion and 6 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 25 Mar 2015. 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 evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy. (time frame: Followed for 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 25 Mar 2015.