Prostate CancerPhase 1/2NCT00456989
Study of Taxotere and Doxil to Treat Advanced Androgen-Independent Prostate Cancer
A Phase 1/2 study testing Taxotere and Doxil in people with Prostate Cancer, run by University of Louisville at 1 site in United States.
Trial summary
This clinical research study is being done because there is no effective treatment for advanced androgen-independent prostate cancer. This study will determine if the combination of medications (Taxotere and Doxil) are effective in this kind of 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?
- Taxotere and Doxil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Aug 2010
- Phase
- Phase 1/2
- 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
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Androgen-independent disease progression, as shown by:
- A castrate testosterone level of < 40 ng/dl (this measurement is required only for patients treated with medical testicular suppression). If testicular suppression is achieved medically, treatment to maintain castrate levels of testosterone must be applied continuously.
- A PSA level of at least 4 ng/ml, and rising (with an absolute change of at least 1 ng/ml) on two consecutive measurements at least 2 weeks apart prior to study entry.
- Patients must be off anti-androgens such as flutamide (Eulexin) or nilutamide (Nilandron) for at least four weeks, and six weeks for bicalutamide (Casodex), without evidence of response; or have evidence of progression since anti-androgen withdrawal.
- None or one previous cytotoxic therapy is allowed. (For this study, a combination of agents given at the same period of time is considered one chemotherapy treatment)
Show all 21Show fewer
- Age > 18 years of age.
- Life expectancy of greater than 12 weeks.
- ECOG performance status 0, 1 or 2 (Karnofsky >50%; see Appendix B).
- Patients must have adequate bone marrow function as defined below:
- absolute neutrophil count > 1,500/ul
- platelets > 100,000/ul
- hemoglobin > 8 g/dl
- Patients must have adequate liver function as defined below:
- total bilirubin normal, albumin > 3.0 g/dl, and no ascites
- AST(SGOT) and ALT(SGPT) and Alkaline Phosphatase must be within the range allowing for eligibility
- Patients must have adequate renal function as defined by a creatinine < 2.5 mg/dl or a creatinine clearance > 30 mL/min (measured or estimated by the Cockroft formula) for patients with creatinine levels above 2.5 mg/dl
- Patients must have recovered from acute toxicities from chemotherapy or radiotherapy administered prior to entering this study. Alopecia may not be resolved and peripheral neuropathy (grade 1) may be present.
- Patients must have a MUGA scan or 2-d echocardiogram indicating an ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.
- Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who have had two or more prior chemotherapy treatment(s) (For this study, a combination of agents given at the same period of time is considered one chemotherapy treatment).
- Patients receiving any other investigational agent(s).
- Patients with symptomatic brain metastases or actively receiving any therapy for brain metastasis (because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events).
- Active second malignancy in the last 5 years except for non-melanoma skin cancer or carcinoma-in-situ.
- History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure.
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL, the components of Doxil, docetaxel or other drugs formulated with polysorbate 80.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Phase I/II Study of Docetaxel (Taxotere) in Combination With Doxorubicin HCI Liposome Injection (Doxil) in Advanced Androgen-Independent Prostate Cancer (AIPC)
This clinical research study is being done because there is no effective treatment for advanced androgen-independent prostate cancer. This study will determine if the combination of medications (Taxotere and Doxil) are effective in this kind of cancer.
Read the detailed description
Each cycle of treatment will consist of four weeks. The 2 types of medicines are given intravenously (in a vein). Doxil is given on the first day of each cycle. Taxotere is given once a week for the first 3 weeks of each cycle. This is followed by a week of rest until the next cycle starts. Treatment is given on an outpatient basis and hospitalization is not anticipated.
Prior to entry on this study, "screening" tests are performed to determine eligibility to participate. This will involve a complete history and physical examination, vital signs, pain assessment, blood tests including CBC (complete blood count), serum chemistry, and PSA (prostate specific antigen), x-rays (chest x-ray, possible plain films of bones if there are abnormal findings on bone scan for clarification), computerized tomography (CT) scans of the abdomen and pelvis, bone scans, a MUGA scan or 2-D echocardiogram, and a quality of life questionnaire.
After treatment starts the following tests are done to regularly monitor for beneficial and toxic effect of the treatment:
Every week: blood tests.
Every month: physical examination, weight, vital signs (blood pressure, respiration, temperature and heart rate) and PSA test.
Every 2 months: pain assessment, quality of life questionnaire, x-rays (chest x-ray and possible pain films of bones if positive findings are seen on bone scan), computerized tomography (CT) scans (abdomen and pelvis) and bone scans.
Participants may continue with any procedures that are part of their regular cancer care. It is anticipated that participants will be in the study for a minimum of 2 months and as long as they are benefiting from the treatment.
- Conditions
- Prostate Cancer
- Being tested
- Taxotere, Doxil
- Keywords
- Androgen Independent, Prostate Cancer, Taxotere, Doxil, AIPC, Advanced Androgen-Independent 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.
TaxotereDrug
Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.
DoxilDrug
Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Taxotere and Doxil | Experimental | Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively. Receives: Drug: Taxotere; Drug: Doxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose and Toxicity Profile
Measured: 2 years
Secondary outcomes (1)
Response Rate
Data not analyzed, PI left institution
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startJan 2004
- Primary completionAug 2010
- Study completionAug 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Sponsor
- Investigators
- Damian Laber, MD, Principal investigator, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456989
- Sponsor's protocol ID
- IRB# 575-03
- Status last verified
- Oct 2019
- First submitted
- 4 Apr 2007
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Laber DA, Eatrides J, Jaglal MV, Haider M, Visweshwar N, Patel A. A phase I/II study of docetaxel in combination with pegylated liposomal doxorubicin in metastatic castration-resistant prostate cancer. Med Oncol. 2020 Sep 26;37(10):95. doi: 10.1007/s12032-020-01420-7.
PubMed 32979106
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Docetaxel (Taxotere) in Combination With Doxorubicin HCI Liposome Injection (Doxil) in Advanced Androgen-Independent Prostate Cancer (AIPC)
- ClinicalTrials.gov ID
- NCT00456989
- Acronym / sponsor ID
- IRB# 575-03
- Conditions
- Prostate Cancer
- Keywords
- Androgen Independent, Prostate Cancer, Taxotere, Doxil, AIPC, Advanced Androgen-Independent Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Jan 2004
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Posted 9 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical research study is being done because there is no effective treatment for advanced androgen-independent prostate cancer. This study will determine if the combination of medications (Taxotere and Doxil) are effective in this kind of cancer.
Detailed description
Each cycle of treatment will consist of four weeks. The 2 types of medicines are given intravenously (in a vein). Doxil is given on the first day of each cycle. Taxotere is given once a week for the first 3 weeks of each cycle. This is followed by a week of rest until the next cycle starts. Treatment is given on an outpatient basis and hospitalization is not anticipated.
Prior to entry on this study, "screening" tests are performed to determine eligibility to participate. This will involve a complete history and physical examination, vital signs, pain assessment, blood tests including CBC (complete blood count), serum chemistry, and PSA (prostate specific antigen), x-rays (chest x-ray, possible plain films of bones if there are abnormal findings on bone scan for clarification), computerized tomography (CT) scans of the abdomen and pelvis, bone scans, a MUGA scan or 2-D echocardiogram, and a quality of life questionnaire.
After treatment starts the following tests are done to regularly monitor for beneficial and toxic effect of the treatment:
Every week: blood tests.
Every month: physical examination, weight, vital signs (blood pressure, respiration, temperature and heart rate) and PSA test.
Every 2 months: pain assessment, quality of life questionnaire, x-rays (chest x-ray and possible pain films of bones if positive findings are seen on bone scan), computerized tomography (CT) scans (abdomen and pelvis) and bone scans.
Participants may continue with any procedures that are part of their regular cancer care. It is anticipated that participants will be in the study for a minimum of 2 months and as long as they are benefiting from the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taxotere and Doxil | Experimental | Drug: Taxotere, Drug: DoxilTreatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Androgen-independent disease progression, as shown by:
- A castrate testosterone level of < 40 ng/dl (this measurement is required only for patients treated with medical testicular suppression). If testicular suppression is achieved medically, treatment to maintain castrate levels of testosterone must be applied continuously.
- A PSA level of at least 4 ng/ml, and rising (with an absolute change of at least 1 ng/ml) on two consecutive measurements at least 2 weeks apart prior to study entry.
- Patients must be off anti-androgens such as flutamide (Eulexin) or nilutamide (Nilandron) for at least four weeks, and six weeks for bicalutamide (Casodex), without evidence of response; or have evidence of progression since anti-androgen withdrawal.
Key exclusion criteria (8 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who have had two or more prior chemotherapy treatment(s) (For this study, a combination of agents given at the same period of time is considered one chemotherapy treatment).
- Patients receiving any other investigational agent(s).
- Patients with symptomatic brain metastases or actively receiving any therapy for brain metastasis (because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events).
- Active second malignancy in the last 5 years except for non-melanoma skin cancer or carcinoma-in-situ.
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 |
|---|---|---|
| TaxotereTreatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. | Drug | Taxotere and Doxil |
| DoxilTreatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively. | Drug | Taxotere and Doxil |
Primary outcome
Maximum Tolerated Dose and Toxicity Profile
Time frame: 2 years
1 secondary outcome
Response Rate
Time frame: 7 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32979106Laber DA, Eatrides J, Jaglal MV, Haider M, Visweshwar N, Patel A. A phase I/II study of docetaxel in combination with pegylated liposomal doxorubicin in metastatic castration-resistant prostate cancer. Med Oncol. 2020 Sep 26;37(10):95. doi: 10.1007/s12032-020-01420-7.
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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.
Damian Laber, MD principal investigator
James Graham Brown 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 1/2 study testing Taxotere and Doxil in people with Prostate Cancer, run by University of Louisville 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 21 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: finished, as of the sponsor's last update on 30 Oct 2019. 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 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?
Yes. Results are posted in the registry (first posted 9 Oct 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?
Maximum Tolerated Dose and Toxicity Profile (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00456989, which also lists 1 linked publication.
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 30 Oct 2019.