Prostatic NeoplasmsPhase 2NCT00521781
Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
A Phase 2 study testing Abraxane, Leuprolide and Bicalutamide in people with Prostatic Neoplasms, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of the clinical trial is to assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate, as well as to assess safety and tolerability of the study drug… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Abraxane, Leuprolide and Bicalutamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Oct 2008
- 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
- Histologic proof of adenocarcinoma of the prostate.
- Patients must belong to one of four groups: 1) Local/Regional with prior definitive therapy: Patients with local/regional recurrence following prostatectomy or radiation therapy who still have a normal bone scan. 2) Local/Regional without prior definitive therapy: Patients felt to be unresectable, or are felt not to be candidates for, radiation therapy. 3) Low volume bone disease: Patients with 1 or 2 bone metastases. 4) High volume bone/visceral disease: Patients with ≥ 3 metastatic bone sites or visceral metastases.
- Patients meeting these criteria are eligible even without any radiographically demonstrable abnormality. All patients must have an elevated PSA prior to initial hormone exposure defined as: 1) For patients with prior prostatectomy, the PSA must be rising with an associated doubling time of ≤ 3 months. 2) For patients with prior radiation therapy, the PSA must be ≥ 1.0 ng/mL with an associated doubling time of ≤ 3 months. 3) For patients with the prostate in place, the PSA must be elevated with biopsy proven disease and are not candidates for local therapy.
- Patients may be on an LHRH agonist (with or without an anti-androgen), or already medically castrated, at the time of study entry, provided such therapy was started within 3 months of study entry.
- No previous cytotoxic systemic therapy of any kind is allowed, including systemic irradiation with strontium-89 and samarium. Previous definitive radiotherapy to one metastatic site is acceptable. At least 8 weeks must have elapsed since radiation therapy to the pelvis. Patients having limited irradiation of a single metastatic site are eligible 4 weeks following the completion of radiation.
- Patients may have had previous exposure to androgen deprivation therapy if it was given for ≤ 6 months to, "downstage" the primary, and provided such therapy completed at least 12 months prior to entry into this study.
- Patients must be free of serious co-morbidity and have a life expectancy of ≥ 3 years.
- Patients must have adequate physiologic reserves as evidenced by Zubrod Performance Status (ZPS) of ≤ 2, adequate bone marrow function, renal function and liver function and no evidence of active ischemia on ECG (if clinically indicated, documentation of EF ≥ 40%.)
Who cannot join
- Patients must not have a second malignancy unless there is confidence of previous curative therapy.
- Patients with a recent history of TIA (within 6 months), or are requiring regular antianginal therapy or are having claudication sufficient to limit activity are not eligible. Patients with a previous history of deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible.
- Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
- Patients must not have Sensory neuropathy of grade 1 or greater.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine - Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Phase II Trial of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Adenocarcinoma of the Prostate
The purpose of the clinical trial is to assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate, as well as to assess safety and tolerability of the study drug regimen and to evaluate secondary efficacy endpoints such as overall survival and duration of response.
Read the detailed description
Abraxane is a potent anticancer drug that stops cancer cells from growing and dividing by interfering with certain cell structures and killing the cancer cells. Abraxane is the first albumin-bound taxane particle of approximately 130 nanometers that takes advantage of albumin, a natural carrier of water-insoluble molecules (e.g., various nutrients, vitamins, and hormones) found in humans. Albumin is a protein that acts as the body's key transporter of nutrients and other water-insoluble molecules and selectively accumulates in tumor tissues.
The delivery of chemotherapy/hormone therapy in a setting of androgen-independent prostate cancer has demonstrated: survival benefit associated with a PSA decline and tolerable toxicity, thus strongly suggesting that disease modifying potential exists. Preclinical data supports the benefit of simultaneous chemotherapy/hormonal therapy and androgen deprivation. The stage is set for chemotherapy/hormonal therapy to be given earlier in men with prostate cancer. Data suggests a transformation from an androgen-dependent to an androgen-independent phenotype is mediated by the expansion of an androgen-independent clone already present at the time of androgen deprivation. If this model is correct, it would be feasible to bring chemotherapy/hormonal therapy up front when the corresponding tumor burden is minimal.
It is hoped that by bringing therapy against all components of the tumor initially, the emergence of androgen-independent growth will be delayed, ultimately prolonging patient survival. This study will test this hypothesis of Abraxane plus hormonal therapy followed by standard hormonal therapy.
- Conditions
- Prostatic Neoplasms
- Being tested
- Abraxane, Leuprolide, Bicalutamide
- Keywords
- Unresectable or Metastatic Adenocarcinoma Prostate Cancer, Hormonal Therapy, Abraxane, M3thodist
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
100 mg/m2 IVPB Day 1, 8, 15, 22, 29,36,43,50 of each cycle for 4 nine-week cycles (Each cycle of Abraxane/hormonal therapy will consist of 8 weeks of Abraxane therapy and 1 week of rest.)
LeuprolideDrug
Also called Depot Lupron®, LHRH agonist
7.5 mg monthly or 22.5 mg quarterly, can begin within 3 months of initiating Abraxane for 2 years
BicalutamideDrug
Also called Casodex®, Anti-androgen therapy
50 mg p.o. daily starts week 36 of initiating Abraxane.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment will be Abraxane/hormonal therapy (LHRH Agonist) for four nine-week cycles, followed by Total androgen blockade therapy (LHRH Agonist+ Anti-androgen) for 2 years from the time the hormonal therapy was started. Receives: Drug: Abraxane; Drug: Leuprolide; Drug: Bicalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate.
Measured: measurements every 4 wks while on Abraxane; then every 12 wks
Secondary outcomes (1)
Assess safety and tolerability of the study drug regimen. Overall survival Duration of response PSA "lead-time" to symptomatic or radiographic progression.
Measured: AEs as occur
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionOct 2008
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Robert J Amato, DO, Principal investigator, Baylor College of Medicine - Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521781
- Sponsor's protocol ID
- HMRI IRB#0407-0035
- Other IDs
- PCa-07-102
- Status last verified
- Mar 2016
- First submitted
- 24 Aug 2007
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00521781
- Acronym / sponsor ID
- HMRI IRB#0407-0035
- Conditions
- Prostatic Neoplasms
- Keywords
- Unresectable or Metastatic Adenocarcinoma Prostate Cancer, Hormonal Therapy, Abraxane, M3thodist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 28 Aug 2007 (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 purpose of the clinical trial is to assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate, as well as to assess safety and tolerability of the study drug regimen and to evaluate secondary efficacy endpoints such as overall survival and duration of response.
Detailed description
Abraxane is a potent anticancer drug that stops cancer cells from growing and dividing by interfering with certain cell structures and killing the cancer cells. Abraxane is the first albumin-bound taxane particle of approximately 130 nanometers that takes advantage of albumin, a natural carrier of water-insoluble molecules (e.g., various nutrients, vitamins, and hormones) found in humans. Albumin is a protein that acts as the body's key transporter of nutrients and other water-insoluble molecules and selectively accumulates in tumor tissues.
The delivery of chemotherapy/hormone therapy in a setting of androgen-independent prostate cancer has demonstrated: survival benefit associated with a PSA decline and tolerable toxicity, thus strongly suggesting that disease modifying potential exists. Preclinical data supports the benefit of simultaneous chemotherapy/hormonal therapy and androgen deprivation. The stage is set for chemotherapy/hormonal therapy to be given earlier in men with prostate cancer. Data suggests a transformation from an androgen-dependent to an androgen-independent phenotype is mediated by the expansion of an androgen-independent clone already present at the time of androgen deprivation. If this model is correct, it would be feasible to bring chemotherapy/hormonal therapy up front when the corresponding tumor burden is minimal.
It is hoped that by bringing therapy against all components of the tumor initially, the emergence of androgen-independent growth will be delayed, ultimately prolonging patient survival. This study will test this hypothesis of Abraxane plus hormonal therapy followed by standard hormonal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Abraxane, Drug: Leuprolide, Drug: BicalutamideTreatment will be Abraxane/hormonal therapy (LHRH Agonist) for four nine-week cycles, followed by Total androgen blockade therapy (LHRH Agonist+ Anti-androgen) for 2 years from the time the hormonal therapy was started. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologic proof of adenocarcinoma of the prostate.
- Patients must belong to one of four groups: 1) Local/Regional with prior definitive therapy: Patients with local/regional recurrence following prostatectomy or radiation therapy who still have a normal bone scan. 2) Local/Regional without prior definitive therapy: Patients felt to be unresectable, or are felt not to be candidates for, radiation therapy. 3) Low volume bone disease: Patients with 1 or 2 bone metastases. 4) High volume bone/visceral disease: Patients with ≥ 3 metastatic bone sites or visceral metastases.
- Patients meeting these criteria are eligible even without any radiographically demonstrable abnormality. All patients must have an elevated PSA prior to initial hormone exposure defined as: 1) For patients with prior prostatectomy, the PSA must be rising with an associated doubling time of ≤ 3 months. 2) For patients with prior radiation therapy, the PSA must be ≥ 1.0 ng/mL with an associated doubling time of ≤ 3 months. 3) For patients with the prostate in place, the PSA must be elevated with biopsy proven disease and are not candidates for local therapy.
- Patients may be on an LHRH agonist (with or without an anti-androgen), or already medically castrated, at the time of study entry, provided such therapy was started within 3 months of study entry.
- No previous cytotoxic systemic therapy of any kind is allowed, including systemic irradiation with strontium-89 and samarium. Previous definitive radiotherapy to one metastatic site is acceptable. At least 8 weeks must have elapsed since radiation therapy to the pelvis. Patients having limited irradiation of a single metastatic site are eligible 4 weeks following the completion of radiation.
Key exclusion criteria (4 listed)
- Patients must not have a second malignancy unless there is confidence of previous curative therapy.
- Patients with a recent history of TIA (within 6 months), or are requiring regular antianginal therapy or are having claudication sufficient to limit activity are not eligible. Patients with a previous history of deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible.
- Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
- Patients must not have Sensory neuropathy of grade 1 or greater.
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 |
|---|---|---|
| Abraxane100 mg/m2 IVPB Day 1, 8, 15, 22, 29,36,43,50 of each cycle for 4 nine-week cycles (Each cycle of Abraxane/hormonal therapy will consist of 8 weeks of Abraxane therapy and 1 week of rest.) | Drug | 1 |
| LeuprolideAlso: Depot Lupron®, LHRH agonist7.5 mg monthly or 22.5 mg quarterly, can begin within 3 months of initiating Abraxane for 2 years | Drug | 1 |
| BicalutamideAlso: Casodex®, Anti-androgen therapy50 mg p.o. daily starts week 36 of initiating Abraxane. | Drug | 1 |
Primary outcome
Assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate.
Time frame: measurements every 4 wks while on Abraxane; then every 12 wks
1 secondary outcome
Assess safety and tolerability of the study drug regimen. Overall survival Duration of response PSA "lead-time" to symptomatic or radiographic progression.
Time frame: AEs as occur
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Robert J Amato, DO principal investigator
Baylor College of Medicine - Methodist Hospital
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 Abraxane, Leuprolide and Bicalutamide in people with Prostatic Neoplasms, run by The Methodist Hospital Research Institute 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 8 inclusion and 4 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 17 Mar 2016. 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: Sponsor decision). 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?
Assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate. (time frame: measurements every 4 wks while on Abraxane; then every 12 wks). 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 17 Mar 2016.