Prostate CancerPhase 2NCT00589420
Sorafenib and Docetaxel in Patients With Prostate Cancer That Did Not Respond to Previous Hormone Therapy
A Phase 2 study testing docetaxel and sorafenib tosylate in people with Prostate Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- docetaxel and sorafenib tosylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2007to 2 Feb 2011
- Phase
- Phase 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 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
- Serum PSA >5 ng/mL.
- Patients must have discontinued flutamide or nilutamide for at least 4 weeks and bicalutamide for at least 6 weeks
- Disease progression during hormonal therapy defined as at least one of the following:
- increasing serum PSA levels on at least two measurements at least two weeks apart.
- Progressive measurable disease (by RECIST criteria) independent of PSA
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- Bone scan progression with at least one new lesion.
- Serum testosterone ≤ 50 ng/dL. Patients must be receiving primary androgen ablation therapy with a GnRH agonist as maintenance therapy unless surgically castrated.
- Age > 18 years.
- ECOG performance status of ≤ 1.
- Baseline laboratory values (evaluated within 14 days of randomization):
- White Blood Count > 3,000/mm3 Absolute Granulocyte Count > 1,500/mm3 Platelet Count > 100,000/mm3 Serum creatinine < 2.0 x upper limit of normal (ULN) INR < 1.5 before the start of chronic anticoagulation and a PTT within normal limits
- Liver Function Total Bilirubin less or equal to ULN AST and ALT must be <5X ULN for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
- Prior radiation therapy is allowed. However, if radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that lesion to constitute measurable disease or to be included in the measured target lesions. 4 weeks must have elapsed between radiation therapy and entry into study.
- Prior vaccine therapy is allowed
- Prior and/or concurrent zoledronic acid (Zometa) therapy is allowed.
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Who cannot join
- Prior therapy with cytotoxic chemotherapy
- Prior therapy with radioisotopes
- History of brain metastasis or leptomeningeal disease
- Symptomatic neuropathy >grade2
- Prior history of cancer (except basal cell or squamous-cell skin cancer) within the past 5 years (exceptions must be approved by the PI)
- Prior history of DVT or Pulmonary embolism in the last 1 year
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- Patients must not have a serious medical illness including, but not limited to, ongoing or active infection requiring parental antibiotics; clinically significant cardiovascular disease (e.g. uncontrolled hypertension, recent myocardial infarction, unstable angina), New York heart association grade II or greater congestive heart failure, or grade II or greater peripheral arterial vascular within 1 year prior to study entry, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St. John's wort.
- Patients must not be taking drugs that inhibit CYP3A at the time of enrollment to prevent drug-drug interactions with docetaxel. These include ketoconazole, voriconazole, itraconazole, fluconazole, cimetidine, clarithromycin, erythromycin, troleandomycin, and grapefruit juice. These agents should be avoided during treatment while on study.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients are excluded from the study. For patients receiving combination anti-retroviral therapy, the potential impact of pharmacokinetic interactions with sorafenib and docetaxel is unknown. Appropriate studies may be undertaken in patients with HIV and those receiving combination anti-retroviral therapy in the future.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: A Phase II Study of Sorafenib in Combination With Docetaxel in Patients With Androgen-Independent Prostate Cancer
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how well it works in treating patients with metastatic androgen-independent prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the proportion of patients achieving a 50% reduction in serum PSA from baseline in patients with androgen-independent prostate cancer (AIPC) receiving sorafenib tosylate and docetaxel.
Secondary
- To estimate the progression-free survival of patients with AIPC.
- To quantify the number and percent of patients who have stable disease at 6 months of therapy (failure to progress).
- To estimate median time to progression for all patients.
- To estimate the objective response rate of patients with AIPC treated with this regimen.
- To measure the percentage of patients surviving at 2 years.
- To determine the toxicities and estimate toxicity rates for patients treated with this regimen.
- To measure changes in tumor vasculature in response to therapy in selected patients with dynamic contrast-enhanced MRI (DCE-MRI) and correlate primary and secondary objectives to these measurement changes.
- To measure changes in serum HMGB1 in response to therapy and correlate primary and secondary objectives with these changes.
- To measure changes in serum cathepsin D in response to therapy and correlate primary and secondary objectives with these changes.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 2-19 and docetaxel IV on day 1. Treatment repeats every 21 days for up to 10 courses. Patients then receive oral sorafenib tosylate alone twice daily on days 1-19 with treatment repeating every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically to measure serum HMGB1 and cathepsin D levels before and after therapy.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel, sorafenib tosylate
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV 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.
docetaxelDrug
Also called Taxotere
sorafenib tosylateDrug
Also called Nexavar
| Study group | Role | What they receive |
|---|---|---|
| Phase II | Experimental | All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks Receives: Drug: docetaxel; Drug: sorafenib tosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Specific Antigen (PSA) Response Rate
PSA Response: ≥50% decline from baseline PSA measurement confirmed by a second PSA measurement 3 weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression.
PSA progression (PSA-P): Two measurements of rising serum PSA measured at least 2 weeks apart where the second is greater than the first.
Measured: From start of treatment until withdrawal from the study, approximately 12 months
Secondary outcomes (2)
6-month Progression-free Survival (PFS)
Number of patients that achieved 6 month PFS
Measured: 6 months from end of treatment
Objective Response Rate (ORR)
To determine the ORR in patients with measurable disease
Measured: 6 months from end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study start27 Jul 2007
- Primary completion2 Feb 2010
- Study completion2 Feb 2011
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.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Amaravadi, RN, MPA, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589420
- Sponsor's protocol ID
- UPCC 03806
- Other IDs
- 805372, CDR0000581020
- Status last verified
- Feb 2022
- First submitted
- 25 Dec 2007
- Last updated
- 17 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Sharing of IPD will be done on a case by case basis
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sorafenib in Combination With Docetaxel in Patients With Androgen-Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00589420
- Acronym / sponsor ID
- UPCC 03806
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Sanofi, Bayer
- Study start
- 27 Jul 2007 (actual)
- Primary completion
- 2 Feb 2010 (actual)
- Study completion
- 2 Feb 2011 (actual)
- First posted
- 9 Jan 2008 (estimated)
- Results
- Posted 17 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how well it works in treating patients with metastatic androgen-independent prostate cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the proportion of patients achieving a 50% reduction in serum PSA from baseline in patients with androgen-independent prostate cancer (AIPC) receiving sorafenib tosylate and docetaxel.
Secondary
- To estimate the progression-free survival of patients with AIPC.
- To quantify the number and percent of patients who have stable disease at 6 months of therapy (failure to progress).
- To estimate median time to progression for all patients.
- To estimate the objective response rate of patients with AIPC treated with this regimen.
- To measure the percentage of patients surviving at 2 years.
- To determine the toxicities and estimate toxicity rates for patients treated with this regimen.
- To measure changes in tumor vasculature in response to therapy in selected patients with dynamic contrast-enhanced MRI (DCE-MRI) and correlate primary and secondary objectives to these measurement changes.
- To measure changes in serum HMGB1 in response to therapy and correlate primary and secondary objectives with these changes.
- To measure changes in serum cathepsin D in response to therapy and correlate primary and secondary objectives with these changes.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 2-19 and docetaxel IV on day 1. Treatment repeats every 21 days for up to 10 courses. Patients then receive oral sorafenib tosylate alone twice daily on days 1-19 with treatment repeating every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically to measure serum HMGB1 and cathepsin D levels before and after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase II | Experimental | Drug: docetaxel, Drug: sorafenib tosylateAll patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
- Serum PSA >5 ng/mL.
- Patients must have discontinued flutamide or nilutamide for at least 4 weeks and bicalutamide for at least 6 weeks
- Disease progression during hormonal therapy defined as at least one of the following:
- Serum testosterone ≤ 50 ng/dL. Patients must be receiving primary androgen ablation therapy with a GnRH agonist as maintenance therapy unless surgically castrated.
Key exclusion criteria (11 listed)
- Prior therapy with cytotoxic chemotherapy
- Prior therapy with radioisotopes
- History of brain metastasis or leptomeningeal disease
- Symptomatic neuropathy >grade2
- Prior history of cancer (except basal cell or squamous-cell skin cancer) within the past 5 years (exceptions must be approved by the PI)
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 |
|---|---|---|
| docetaxelAlso: Taxotere | Drug | Phase II |
| sorafenib tosylateAlso: Nexavar | Drug | Phase II |
Primary outcome
Prostate Specific Antigen (PSA) Response Rate
Time frame: From start of treatment until withdrawal from the study, approximately 12 months
PSA Response: ≥50% decline from baseline PSA measurement confirmed by a second PSA measurement 3 weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression. PSA progression (PSA-P): Two measurements of rising serum PSA measured at least 2 weeks apart where the second is greater than the first.
2 secondary outcomes
6-month Progression-free Survival (PFS)
Time frame: 6 months from end of treatment
Objective Response Rate (ORR)
Time frame: 6 months from end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Sharing of IPD will be done on a case by case basis
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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.
Ravi Amaravadi, RN, MPA principal investigator
Abramson Cancer Center at Penn Medicine
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 docetaxel and sorafenib tosylate in people with Prostate Cancer, run by Abramson Cancer Center at Penn Medicine 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 17 inclusion and 11 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 17 Feb 2022. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2022). 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?
Prostate Specific Antigen (PSA) Response Rate (time frame: From start of treatment until withdrawal from the study, approximately 12 months). 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 Feb 2022.