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Hormone-Resistant Prostate CancerPhase 2NCT01145508

Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

A Phase 2 study testing Docetaxel, Laboratory Biomarker Analysis and Prednisone in people with Hormone-Resistant Prostate Cancer and Prostate Adenocarcinoma, run by National Cancer Institute (NCI) at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase II trial studies how well docetaxel and prednisone with or without vaccine therapy works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Docetaxel, Laboratory Biomarker Analysis and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
14 sitesUnited States
Study dates
Aug 2010to Oct 2015
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
  • Patient must have metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (computed tomography [CT] of abdomen/pelvis, bone scintigraphy)
  • Patient must have castrate-resistant disease, defined as follows:
  • Patient must have received standard of care androgen deprivation treatment (ADT) before trial entry (surgical castration versus gonadotropin-releasing hormone [GnRH] analogue or antagonist treatment); subjects receiving GnRH analogue or antagonist must continue this treatment throughout the time on this study
  • Patient must have been treated previously with a nonsteroidal antiandrogen, with evidence of subsequent disease progression; subjects must be off use of anti-androgen for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to randomization; subjects who demonstrate an anti-androgen withdrawal response, defined as a >= 25% decline in PSA within 4-6 week of stopping a nonsteroidal antiandrogen are not eligible until the PSA rises above the nadir observed after antiandrogen withdrawal
  • Patient must have castration levels of testosterone (< 50 ng/dL) within 4 weeks prior to randomization
Show all 56Show fewer
  • Patient must have progressive disease while receiving ADT as defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria:
  • PSA: at least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, and each value >= 2.0 ng/mL
  • Measurable disease: >= 50% increase in the sum of the cross products of all measurable lesions or the development of new measurable lesions by RECIST criteria version 1.1; the greatest diameter of a target lesion must be at least 1.0 cm by CT scan (1.5 cm in shortest axis for lymph nodes)
  • Non-measurable (bone) disease: the appearance of two or more new areas of uptake on bone scan consistent with metastatic disease compared to previous imaging during castration therapy; the increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or magnetic resonance imaging [MRI])
  • Patient must not have poor prognosis features suggested by the following required information:
  • Presence of visceral (non-lymph node, non-bone) metastases
  • Poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status [PS] of 2 or greater)
  • Alkaline phosphatase (IU/L) > 2 x institutional upper limit of normal
  • Lactate dehydrogenase (LDH) (U/L) > 2 x institutional upper limit of normal
  • Patient must have an ECOG performance status of 0 or 1
  • White blood cell (WBC) count >= 2000/mm^3
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • Platelet count >= 100,000/mm^3
  • Creatinine =< 2.0 mg/dL
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 1.5 x institutional upper limit of normal (ULN)
  • Total bilirubin < institutional upper limit of normal (ULN)
  • Patient must have completed any prior treatments (apart from androgen deprivation as previously described) >= 4 weeks prior to randomization and have recovered (to < grade 2) from any acute toxicities attributed to this prior treatment
  • Patient must agree to use an accepted and effective method of contraception prior to study entry and for the duration of study participation (or at least 4 months after the last vaccination in subjects receiving vaccine series); if patient impregnates a woman while participating in this study, he should inform his treating physician immediately
  • Patient must not be receiving any other investigational agents or be receiving concurrent anticancer therapy other than ADT
  • Patient must not have been treated with a prior anti-cancer vaccine (including sipuleucel-T, Provenge®)
  • Patient must not have received treatment with any of the following medications within 4 weeks of randomization or while on study:
  • Systemic corticosteroids (excluding prednisone and dexamethasone administered as part of study protocol); inhaled, intranasal or topical corticosteroids are acceptable; steroid eye drops are contraindicated however, for 2 weeks prior to vaccination and for at least 4 weeks after vaccinia vaccination
  • PC-SPES
  • Saw palmetto
  • Megestrol
  • Ketoconazole
  • 5-alpha-reductase inhibitors - patients already taking 5-alpha-reductase inhibitors prior to 28 days prior to randomization may stay on these agents throughout the course of therapy, but these should not be started while patients are on study
  • Diethyl stilbestrol
  • Any other hormonal agent or supplement with possible anti-cancer activity
  • Patient must not have been treated with external beam radiation therapy within 4 weeks of randomization
  • Patient must not have received prior radiation therapy to > 30% of bone marrow
  • Patient must not have had surgery within 4 weeks of randomization
  • Patient must not have received prior chemotherapy within 6 months of randomization; prior and/or concurrent treatment with bisphosphonates, however, is permitted
  • Patient must not have received prior chemotherapy for metastatic prostate cancer
  • Patient cannot have a known history of human immunodeficiency virus (HIV) 1 or 2, human T-lymphotropic virus (HTLV)-1, hepatitis B, or hepatitis C (or any other potentially immunosuppressive infection); eligible subjects must have negative serologic testing for HIV, hepatitis B surface antigen, and hepatitis C
  • Patient cannot have a history of autoimmune disease requiring active immunosuppressive therapy or have organ dysfunction >= grade 2 as a result of known autoimmune disease; eligible subjects must have antinuclear antibodies (ANA) titer < 1:320
  • Patient must not have undergone splenectomy
  • Patient must not have other active malignancies other than non-melanoma skin cancers or carcinoma in situ of the bladder; subjects with a history of other cancers who have been adequately treated and have been recurrence-free for >= 3 years are eligible
  • Patient cannot have a known allergy to eggs
  • Patient cannot have a known intolerance or allergic reactions to docetaxel or compounds of similar chemical or biologic composition
  • Patient cannot have a known history of allergy or intolerable reaction to a previous vaccinia virus vaccination (e.g., smallpox)
  • Patient or close household contacts of patient (those who share housing or have close physical contact with the patient) cannot have close physical contact to persons with the following conditions within 3 weeks after potential vaccinia immunization:
  • A history of eczema, active eczema or other acute, chronic or exfoliative skin conditions, including Darier's disease (e.g. atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or open wounds)
  • Pregnant or nursing women
  • Children under 3 years of age
  • Immunodeficient or immunosuppressed persons (e.g. HIV, or treated for other diseases with immunosuppressive agents)
  • Any other moderate or severe acute illness until the illness resolves Patients who would be unable to avoid these conditions for a 3-week period are not eligible; patients should also refer to the patient instruction sheet for vaccinia virus
  • Patient cannot have known brain metastases
  • Patient cannot have a known history of recent (within 6 months) stroke, myocardial infarction, unstable angina, New York Heart Association class II-IV congestive heart failure, or significant cardiomyopathy requiring treatment
  • Patient cannot take known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) within 2 weeks of beginning docetaxel through its discontinuation; substrates of CYP3A4 with a narrow therapeutic/toxicity window may be used with caution, with prior approval of the study chair or institution's principal investigator (PI)

Who cannot join

None listed.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Hematology Oncology Associates of Illinois-Highland Park

    Highland Park, Illinois, 60035

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Presence Saint Mary's Hospital

    Kankakee, Illinois, 60901

  • NorthShore Hematology Oncology-Libertyville

    Libertyville, Illinois, 60048

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Illinois Cancer Specialists-Niles

    Niles, Illinois, 60714

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Hematology Oncology Associates of Illinois - Skokie

    Skokie, Illinois, 60076

Other trials in United States

About this study

Official title: Randomized Phase II Trial of Docetaxel With or Without PSA-TRICOM Vaccine in Patients With Castrate-Resistant Metastatic Prostate Cancer

This randomized phase II trial studies how well docetaxel and prednisone with or without vaccine therapy works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from an antigen may help the body build an effective immune response to kill tumor cells. It is not yet known whether docetaxel and prednisone are more effective with or without vaccine therapy in treating prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the overall survival in patients treated with PSA-TRICOM (fowlpox-PSA-TRICOM vaccine and rilimogene-galvacirepvec) and docetaxel chemotherapy versus docetaxel chemotherapy only.

SECONDARY OBJECTIVES:

  1. To evaluate the time to radiographic progression after beginning docetaxel chemotherapy in patients previously treated with PSA-TRICOM vaccine versus those not treated with this vaccine.

II. To compare objective responses (according to Response Evaluation Criteria in Solid Tumors [RECIST]) between the two treatment groups in those patients with measurable disease.

III. To evaluate prostate-specific antigen (PSA) response rates (decline >= 50%) in patients treated with PSA-TRICOM and docetaxel chemotherapy versus docetaxel chemotherapy only.

IV. To evaluate immune responses elicited in patients treated before and after docetaxel chemotherapy.

  1. To evaluate the association between development of prostate antigen-specific immune responses and time to progression and overall survival.

VI. To evaluate the association of predicted survival (by Halabi nomogram) with actual survival in patients treated with PSA-TRICOM vaccine versus those not treated with this vaccine.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A (vaccine and chemotherapy): Patients receive rilimogene-galvacirepvec subcutaneously (SC) on day 1 of course 1 and fowlpox-PSA-TRICOM vaccine SC on days 15, 29, 43, and 57 of course 1. Beginning on day 85 (day 1 of course 2), patients receive docetaxel intravenously (IV) over 1 hour on day 1 and prednisone orally (PO) twice daily (BID) on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ARM B (chemotherapy): Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Being tested
Docetaxel, Laboratory Biomarker Analysis, Prednisone, Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine, Rilimogene Galvacirepvec
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 Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given PO

  • Recombinant Fowlpox-PSA(L155)/TRICOM VaccineBiological

    Also called PROSTVAC-F, rFowlpox-PSA(L155)/TRICOM Vaccine

    Given SC

  • Rilimogene GalvacirepvecBiological

    Also called PROSTVAC, Prostvac-V, Recombinant Vaccinia-PSA(L155)-TRICOM Vaccine, Recombinant Vaccinia-PSA(L155)/TRICOM

    Given SC

Study groups in NCT01145508
Study groupRoleWhat they receive
Arm A (vaccine therapy and chemotherapy)ExperimentalPatients receive rilimogene-galvacirepvec SC on day 1 of course 1 and fowlpox-PSA-TRICOM vaccine SC on days 15, 29, 43, and 57 of course 1. Beginning on day 85 (day 1 of course 2), patients receive docetaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Drug: Prednisone; Biological: Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine; Biological: Rilimogene Galvacirepvec
Arm B (docetaxel, prednisone)Active comparatorPatients receive docetaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival is defined as the time from randomization to death or the date of last known alive.

    Measured: Assessed every 3 months for 2 years, and then every 6 months for 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionOct 2012
  4. Study completionOct 2015

Why it stopped: Poor accrual

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01145508
Sponsor's protocol ID
NCI-2011-02048
Other IDs
NCI-2011-02048, CDR0000675173, E1809, E1809, E1809, U10CA180820, U10CA021115
Status last verified
Aug 2017
First submitted
15 Jun 2010
Last updated
19 Sep 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Laboratory Biomarker Analysis and Prednisone in people with Hormone-Resistant Prostate Cancer and Prostate Adenocarcinoma, run by National Cancer Institute (NCI) at 14 sites 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 56 inclusion and 0 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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 23 Jul 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?

Overall Survival (time frame: Assessed every 3 months for 2 years, and then every 6 months for 3 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 NCT01145508.

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 19 Sep 2017.

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