Prostate CancerPhase 2NCT00176293
Randomized Phase II Trial of Doxil With or Without Dexamethasone for Metastatic Hormone Refractory Prostate Cancer
A Phase 2 study testing dexamethasone and doxorubicin in people with Prostate Cancer, run by University of Kentucky at 1 site in United States.
Trial summary
The primary objective of this study is to assess disease response to Doxil in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment. Study Design: We will perform an open labeled, parallel, randomized phase II study using a two-stage design to determine if there is sufficient… 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?
- dexamethasone and doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Feb 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
- Patients with metastatic hormone refractory prostate cancer as defined by resistance to both ablative therapy (with either LHRH agonists or orchiectomy) \& anti-androgens.
- Patients must have symptoms related to disease.
- Patients must have PS 0,1,2 (ECOG).
- Patients must have measurable disease (RECIST) or PSA > 5.
- Patients must have adequate organ function as defined as follows: leukocytes >/= 3,000/mm3, absolute neutrophil count >/= 1,500/mm3, hemoglobin >/= 8.0g/dl, platelets >/= 100,000/mm3, serum creatinine </= 2.5 mg/dl. Bilirubin must be </= 2 fold above ULN. Liver transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional ULN if alkaline phosphatase is </= ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are </= ULN.
- Patients must have a left ventricular ejection fraction (LVEF) 50% by echocardiogram
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- Patients must have failed to respond to discontinuation of anti-androgens.
- No previous therapy with anti-androgens, corticosteroids or estrogens in the last 4 weeks.
- Previous radiation therapy is allowed if completed at least 4 weeks prior to study entry \& therapy was cumulatively administered to </= 25% of bone marrow.
- Patients must be >18 years of age
- Patients must have an expected survival of at least 4 months.
- Patients must have the ability to understand \& the willingness to sign a written informed consent document.
- Patients must be willing to use adequate contraceptive method during treatment and for 3 months after completing treatment.
Who cannot join
- Patients with previous history of cancer are excluded unless they have had curative treatment completed >/= 5 years prior to entry onto study or had 1 of the following: in situ carcinoma (any location), basal cell carcinoma, or non-metastatic squamous cell carcinoma of the skin.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements or the ability to provide informed consent.
- Patients requiring any non study corticosteroids for any reason are excluded.
- Patients who have received previous chemotherapy.
- A history of cardiac disease with New York Heart Class II or greater, or clinical evidence of congestive heart failure.
- Patients may not be receiving any other investigational agents or have participated in any investigational drug study within 4 weeks preceding initiation of treatment.
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- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery.
- Patients with a lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome or inability to swallow tablets.
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Trial of Doxil With or Without Dexamethasone in Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer
The primary objective of this study is to assess disease response to Doxil in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment.
Study Design:
Read more
We will perform an open labeled, parallel, randomized phase II study using a two-stage design to determine if there is sufficient anti-tumor activity in either arm to warrant further study. Assumptions made in this study: an unacceptable overall response rate is </= 10% \& we will pursue further study if the overall response rate is >/= 30%. Fifteen patients will be randomized in the first phase (to both Arm 1 and Arm 2). No further patients will be accrued if <2/15 responses are noted in a given arm. Ten additional patients will be enrolled if >/= 2/15 responses are observed. If there are >/= 5/25 responses then further studies will be pursued with that regimen. We will determine the overall incidence \& severity of toxicities in both arms.
Treatment:
Arm 1: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 2: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 1 only: Dexamethasone: Dose: 12 mg twice a day by mouth on days 1, 2, 3, 4, 5 of each 28 day cycle.
Number of Cycles for both Arm 1 \& 2: until progression or unacceptable toxicity develops.
Read the detailed description
Primary Objectives:
To assess the anti-tumor activity of Doxil by assessing response rates in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment.
Secondary Objectives:
To assess and estimate in patients with hormone refractory prostate cancer treated with Doxil with or without pre-treatment dexamethasone: 1) overall survival 2) toxicity, 3) quality of life parameters, 4) dose intensity administered in both treatment groups.
Study Design:
We will perform an open labeled, parallel, randomized phase II study using a two-stage design to determine if there is sufficient anti-tumor activity in either arm to warrant further study. Assumptions made in this study: an unacceptable overall response rate is </= 10% and we will pursue further study if the overall response rate is >/= 30%. The overall response rate for this study will be based on the total number of responses observed defined as: complete responses + partial responses (both by RECIST)+biochemical responses (in patients with no measurable target lesions a >/= 50% decrease in PSA for >/= 4 weeks). Fifteen patients will be randomized in the first phase (to both Arm 1 and Arm 2). No further patients will be accrued if <2/15 responses are noted in a given arm. Ten additional patients will be enrolled if >/= 2/15 responses are observed. If there are >/= 5/25 responses then further studies will be pursued with that regimen. We will determine the overall incidence and severity of toxicities in both arms.
Treatment:
Arm 1: Doxil: Dose: 50 mg/m2, IV. Frequency: day 5 of each 28 day cycle. Arm 2: Doxil: Dose: 50 mg/m2, IV. Frequency: day 5 of each 28 day cycle. Arm 1 only: Dexamethasone: Dose: 12 mg bid po. Frequency: days 1,2,3,4,5 of each 28 day cycle.
Number of Cycles for both Arm 1 and 2: until progression or unacceptable toxicity develops.
- Conditions
- Prostate Cancer
- Being tested
- dexamethasone, doxorubicin
- Keywords
- prostate, prostate cancer, doxil, dexamethasone, metastatic, hormone refractory
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Also called decadron
oral dexamethasone, 12mg BID on days 1, 2, 3, 4, \& 5 of each 28-day cycle
doxorubicinDrug
Also called Doxil
Doxorubicin 50mg/m^2 I.V. on day 5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | dexamethasone Receives: Drug: dexamethasone; Drug: doxorubicin |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with CR or PR
Measured: evaluated after 2 courses then every other course
Secondary outcomes (7)
Hematologic toxicity
Measured: evaluated @ baseline & 3/wk during treatment or until recovery
Percentage of subjects with >/= Grade 3 hematopoietic & non-hematopoietic toxicities
Measured: labs evaluated @ baseline & 3/wk during treatment or until recovery; toxicity evaluated through treatment or until resolved
Clinical non-hematologic & hematologic toxicity
Measured: continuous throughout study
QOL
Measured: baseline then every other cycle
Fraction delivered vs. intended Doxil
Measured: each dose
Cytokines
Measured: evaluated days 1, 5, 8 every other cycle
Survival
Measured: evaluated through study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Slow accrual
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Investigators
- John Rinehart, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176293
- Sponsor's protocol ID
- 04-GU-52-B
- Status last verified
- Apr 2015
- First submitted
- 13 Sep 2005
- Last updated
- 21 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Doxil With or Without Dexamethasone in Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00176293
- Acronym / sponsor ID
- 04-GU-52-B
- Conditions
- Prostate Cancer
- Keywords
- prostate, prostate cancer, doxil, dexamethasone, metastatic, hormone refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Study start
- Oct 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 15 Sep 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 of this study is to assess disease response to Doxil in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment.
Study Design:
We will perform an open labeled, parallel, randomized phase II study using a two-stage design to determine if there is sufficient anti-tumor activity in either arm to warrant further study. Assumptions made in this study: an unacceptable overall response rate is </= 10% \& we will pursue further study if the overall response rate is >/= 30%. Fifteen patients will be randomized in the first phase (to both Arm 1 and Arm 2). No further patients will be accrued if <2/15 responses are noted in a given arm. Ten additional patients will be enrolled if >/= 2/15 responses are observed. If there are >/= 5/25 responses then further studies will be pursued with that regimen. We will determine the overall incidence \& severity of toxicities in both arms.
Treatment:
Arm 1: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 2: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 1 only: Dexamethasone: Dose: 12 mg twice a day by mouth on days 1, 2, 3, 4, 5 of each 28 day cycle.
Number of Cycles for both Arm 1 \& 2: until progression or unacceptable toxicity develops.
Detailed description
Primary Objectives:
To assess the anti-tumor activity of Doxil by assessing response rates in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment.
Secondary Objectives:
To assess and estimate in patients with hormone refractory prostate cancer treated with Doxil with or without pre-treatment dexamethasone: 1) overall survival 2) toxicity, 3) quality of life parameters, 4) dose intensity administered in both treatment groups.
Study Design:
We will perform an open labeled, parallel, randomized phase II study using a two-stage design to determine if there is sufficient anti-tumor activity in either arm to warrant further study. Assumptions made in this study: an unacceptable overall response rate is </= 10% and we will pursue further study if the overall response rate is >/= 30%. The overall response rate for this study will be based on the total number of responses observed defined as: complete responses + partial responses (both by RECIST)+biochemical responses (in patients with no measurable target lesions a >/= 50% decrease in PSA for >/= 4 weeks). Fifteen patients will be randomized in the first phase (to both Arm 1 and Arm 2). No further patients will be accrued if <2/15 responses are noted in a given arm. Ten additional patients will be enrolled if >/= 2/15 responses are observed. If there are >/= 5/25 responses then further studies will be pursued with that regimen. We will determine the overall incidence and severity of toxicities in both arms.
Treatment:
Arm 1: Doxil: Dose: 50 mg/m2, IV. Frequency: day 5 of each 28 day cycle. Arm 2: Doxil: Dose: 50 mg/m2, IV. Frequency: day 5 of each 28 day cycle. Arm 1 only: Dexamethasone: Dose: 12 mg bid po. Frequency: days 1,2,3,4,5 of each 28 day cycle.
Number of Cycles for both Arm 1 and 2: until progression or unacceptable toxicity develops.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: dexamethasone, Drug: doxorubicindexamethasone |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with metastatic hormone refractory prostate cancer as defined by resistance to both ablative therapy (with either LHRH agonists or orchiectomy) \& anti-androgens.
- Patients must have symptoms related to disease.
- Patients must have PS 0,1,2 (ECOG).
- Patients must have measurable disease (RECIST) or PSA > 5.
- Patients must have adequate organ function as defined as follows: leukocytes >/= 3,000/mm3, absolute neutrophil count >/= 1,500/mm3, hemoglobin >/= 8.0g/dl, platelets >/= 100,000/mm3, serum creatinine </= 2.5 mg/dl. Bilirubin must be </= 2 fold above ULN. Liver transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional ULN if alkaline phosphatase is </= ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are </= ULN.
Key exclusion criteria (9 listed)
- Patients with previous history of cancer are excluded unless they have had curative treatment completed >/= 5 years prior to entry onto study or had 1 of the following: in situ carcinoma (any location), basal cell carcinoma, or non-metastatic squamous cell carcinoma of the skin.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements or the ability to provide informed consent.
- Patients requiring any non study corticosteroids for any reason are excluded.
- Patients who have received previous chemotherapy.
- A history of cardiac disease with New York Heart Class II or greater, or clinical evidence of congestive heart failure.
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 |
|---|---|---|
| dexamethasoneAlso: decadronoral dexamethasone, 12mg BID on days 1, 2, 3, 4, \& 5 of each 28-day cycle | Drug | 1 |
| doxorubicinAlso: DoxilDoxorubicin 50mg/m^2 I.V. on day 5 | Drug | 1 |
Primary outcome
Percentage of subjects with CR or PR
Time frame: evaluated after 2 courses then every other course
7 secondary outcomes
Hematologic toxicity
Time frame: evaluated @ baseline & 3/wk during treatment or until recovery
Percentage of subjects with >/= Grade 3 hematopoietic & non-hematopoietic toxicities
Time frame: labs evaluated @ baseline & 3/wk during treatment or until recovery; toxicity evaluated through treatment or until resolved
Clinical non-hematologic & hematologic toxicity
Time frame: continuous throughout study
QOL
Time frame: baseline then every other cycle
Fraction delivered vs. intended Doxil
Time frame: each dose
Cytokines
Time frame: evaluated days 1, 5, 8 every other cycle
Survival
Time frame: evaluated through study
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 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.
John Rinehart, MD principal investigator
University of Kentucky
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 dexamethasone and doxorubicin in people with Prostate Cancer, run by University of Kentucky 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 13 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: stopped early, as of the sponsor's last update on 21 Apr 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 was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
Percentage of subjects with CR or PR (time frame: evaluated after 2 courses then every other course). 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 21 Apr 2015.