Prostate CancerPhase 2NCT00284752
Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer
A Phase 2 study testing Abraxane in people with Prostate Cancer, run by Kaiser Permanente at 1 site in United States.
Trial summary
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response 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?
- Abraxane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2011
- 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
- Histopathologically or cytologically proven adenocarcinoma of the prostate metastatic to the bones or lymph nodes as documented by bone scan or CT scan with evidence of progression despite standard hormonal management (orchiectomy, GNRH agonist, or GNRH antagonist-hormone refractory). No major organ allowed
- No prior chemotherapy
- For patients who have been on anti-androgen therapy, patients must have progressive disease after anti-androgen withdrawal (6 weeks biclutamide or nilutamide, 4 weeks for flutamide).
- PSA progression is defined as rising PSA.
Who cannot join
- Active malignancy other than non-melanoma skin cancer within 5 years of enrollment.
- Significant active medical illness which in the opinion of the investigator will preclude treatment.
- Brain metastasis, any non-bone metastasis except lymph node metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response
Read the detailed description
Taxanes are the most widely tested and effective chemotherapy drugs for hormone refractory prostate cancer. Weekly paclitaxel was reported to produce 25-39% PSA responses in first line and up to 33% in second line chemotherapy of patients with prostate cancer in early clinical trials (1, 2). Paclitaxel activity in prostate cancer is schedule dependent, and weekly paclitaxel was reported to produce highest response rates (1, 2). Docetaxel was recently approved by the Food and Drug Administration for treatment of hormone refractory metastatic prostate cancer, since it is the only chemotherapy drug with documented improvement in survival in this group of patients. Docetaxel was associated with 45.8% overall grade 3/4 toxicities and it has to be given with steroid pre-medication. This regimen might be difficult to use in advanced prostate cancer patients that are often elderly and with multiple co-morbid conditions.
ABI-007 [Abraxane™ (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)] is the first in its class of biologically interactive albumin-bound forms of chemotherapy (3). This composition provides a novel approach of increasing intra-tumoral concentration of the drug by a receptor-mediated transport process allowing transcytosis across the endothelial cell wall, thereby breaching the blood/tumor interface. This albumin-specific receptor mediated process involves the binding of a specific receptor (gp60) on the endothelial cell wall, resulting in activation of a protein caveolin-1, which initiates an opening in the endothelial wall with formation of a little caves or caveolae, with transport of the albumin-bound chemotherapeutic complex via these caveolae to the underlying tumor interstitium (4). A protein specifically secreted by the tumor (SPARC) binds and entraps the albumin, allowing release of the hydrophobic drug to the tumor cell membrane. ABI-007 is the first biologically interactive albumin-bound chemotherapy agent leveraging this gp-60/caveolin-1/caveolae/Sparc pathway to increase intra-tumoral concentration of the drug and reduce the amount of the toxic chemotherapy in normal tissue.
Preclinical studies comparing Abraxane to paclitaxel demonstrated lower toxicities, with a maximum tolerated dose (MTD) approximately 50% higher for Abraxane (7) compared to paclitaxel (11). At equal doses there was less myelosuppression and improved efficacy than paclitaxel in a xenograft tumor model of human mammary adenocarcinoma. Clinical studies confirmed improved toxicity profile and higher response rates, in metastatic breast cancer, of Abraxane compared to cremophor EL paclitaxel (Taxol) (5, 8). The weekly regimen was shown to be active even in patients with cancers refractory to paclitaxel, docetaxel or when Abraxane was given after both agents (8).
- Conditions
- Prostate Cancer
- Being tested
- Abraxane
- Keywords
- Prostate, Cancer, Metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
This is a Phase II single-arm study for first-line chemotherapy of patients with hormone refractory metastatic prostate cancer. Eligible patients will be chemotherapy naive and will receive weekly Abraxane 100mg/m2 IV over 30 minutes. These will be 4-week cycles with patients receiving Abraxane 100 mg/m2 weekly for 3 weeks and one week off for rest. Patients will continue on therapy until disease or PSA
| Study group | Role | What they receive |
|---|---|---|
| ABI-007 | Experimental | Not described Receives: Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with
Measured: August 2008
hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response
Measured: August 2008
Secondary outcomes (2)
Evaluate the effect of Abraxane on,Time to PSA progression, Measurable tumor response rate (if measureable disease at baseline), Overall survival
Measured: August 2008
Evaluate the toxicity of Abraxane in this group of patients.
Measured: August 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startAug 2005
- Primary completionOct 2007
- Study completionDec 2011
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 Kaiser PermanenteThe 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Tatjana Kolevska, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284752
- Sponsor's protocol ID
- TK001
- Status last verified
- Sep 2012
- First submitted
- 30 Jan 2006
- Last updated
- 1 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00284752
- Acronym / sponsor ID
- TK001
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Aug 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Feb 2006 (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.
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response
Detailed description
Taxanes are the most widely tested and effective chemotherapy drugs for hormone refractory prostate cancer. Weekly paclitaxel was reported to produce 25-39% PSA responses in first line and up to 33% in second line chemotherapy of patients with prostate cancer in early clinical trials (1, 2). Paclitaxel activity in prostate cancer is schedule dependent, and weekly paclitaxel was reported to produce highest response rates (1, 2). Docetaxel was recently approved by the Food and Drug Administration for treatment of hormone refractory metastatic prostate cancer, since it is the only chemotherapy drug with documented improvement in survival in this group of patients. Docetaxel was associated with 45.8% overall grade 3/4 toxicities and it has to be given with steroid pre-medication. This regimen might be difficult to use in advanced prostate cancer patients that are often elderly and with multiple co-morbid conditions.
ABI-007 [Abraxane™ (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)] is the first in its class of biologically interactive albumin-bound forms of chemotherapy (3). This composition provides a novel approach of increasing intra-tumoral concentration of the drug by a receptor-mediated transport process allowing transcytosis across the endothelial cell wall, thereby breaching the blood/tumor interface. This albumin-specific receptor mediated process involves the binding of a specific receptor (gp60) on the endothelial cell wall, resulting in activation of a protein caveolin-1, which initiates an opening in the endothelial wall with formation of a little caves or caveolae, with transport of the albumin-bound chemotherapeutic complex via these caveolae to the underlying tumor interstitium (4). A protein specifically secreted by the tumor (SPARC) binds and entraps the albumin, allowing release of the hydrophobic drug to the tumor cell membrane. ABI-007 is the first biologically interactive albumin-bound chemotherapy agent leveraging this gp-60/caveolin-1/caveolae/Sparc pathway to increase intra-tumoral concentration of the drug and reduce the amount of the toxic chemotherapy in normal tissue.
Preclinical studies comparing Abraxane to paclitaxel demonstrated lower toxicities, with a maximum tolerated dose (MTD) approximately 50% higher for Abraxane (7) compared to paclitaxel (11). At equal doses there was less myelosuppression and improved efficacy than paclitaxel in a xenograft tumor model of human mammary adenocarcinoma. Clinical studies confirmed improved toxicity profile and higher response rates, in metastatic breast cancer, of Abraxane compared to cremophor EL paclitaxel (Taxol) (5, 8). The weekly regimen was shown to be active even in patients with cancers refractory to paclitaxel, docetaxel or when Abraxane was given after both agents (8).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABI-007 | Experimental | Drug: Abraxane |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histopathologically or cytologically proven adenocarcinoma of the prostate metastatic to the bones or lymph nodes as documented by bone scan or CT scan with evidence of progression despite standard hormonal management (orchiectomy, GNRH agonist, or GNRH antagonist-hormone refractory). No major organ allowed
- No prior chemotherapy
- For patients who have been on anti-androgen therapy, patients must have progressive disease after anti-androgen withdrawal (6 weeks biclutamide or nilutamide, 4 weeks for flutamide).
- PSA progression is defined as rising PSA.
Key exclusion criteria (3 listed)
- Active malignancy other than non-melanoma skin cancer within 5 years of enrollment.
- Significant active medical illness which in the opinion of the investigator will preclude treatment.
- Brain metastasis, any non-bone metastasis except lymph node metastasis
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 |
|---|---|---|
| AbraxaneThis is a Phase II single-arm study for first-line chemotherapy of patients with hormone refractory metastatic prostate cancer. Eligible patients will be chemotherapy naive and will receive weekly Abraxane 100mg/m2 IV over 30 minutes. These will be 4-week cycles with patients receiving Abraxane 100 mg/m2 weekly for 3 weeks and one week off for rest. Patients will continue on therapy until disease or PSA | Drug | ABI-007 |
Primary outcome
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with
Time frame: August 2008
hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response
Time frame: August 2008
2 secondary outcomes
Evaluate the effect of Abraxane on,Time to PSA progression, Measurable tumor response rate (if measureable disease at baseline), Overall survival
Time frame: August 2008
Evaluate the toxicity of Abraxane in this group of patients.
Time frame: August 2008
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 1 Oct 2012.
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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.
Tatjana Kolevska, MD principal investigator
Kaiser Permanente
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 in people with Prostate Cancer, run by Kaiser Permanente 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 4 inclusion and 3 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 1 Oct 2012. 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?
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with (time frame: August 2008). The study lists 2 primary outcomes in all. 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 1 Oct 2012.