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Hormone Refractory Prostate CancerPhase 2NCT01518283

Study of Weekly Cabazitaxel for Advanced Prostate Cancer

A Phase 2 study testing Cabazitaxel 10 mg/m2 in people with Hormone Refractory Prostate Cancer, run by Spanish Oncology Genito-Urinary Group at 12 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with Docetaxel. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Hormone Refractory Prostate Cancer
What is being tested?
Cabazitaxel 10 mg/m2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
12 sitesSpain
Study dates
May 2012to Jul 2016
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 who have given written informed consent.
  • Age ≥ 18 years.
  • ECOG 0-2.
  • Patients with a histologic or cytologic diagnosis of advanced prostate cancer (any Gleason grade).
  • Previous and ongoing castration by orchiectomy or LHRH agonists. Antiandrogen must be discontinued prior to study start.
  • Disease progression, clinically or radiologically documented, during or after treatment with docetaxel, with a minimum cumulative dose of 225 mg/m2.
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  • "Unfit" patients defined as patients who satisfy at least one of the following criteria:
  • ECOG 2
  • Dose reduction due to febrile neutropenia during the previous treatment with docetaxel
  • Radiation therapy affecting more than 25% of bone marrow reserve
  • Documented metastatic disease and progressing after docetaxel treatment. Progression criteria is considered any of the following three or more than one at once:
  • Progressive elevation of PSA measured in three successive determinations one week difference between them at least;
  • Should be considered progression of measurable disease by RECIST criteria;
  • Bone progression as evidenced by the appearance of two or more new lesions on bone scan.
  • Patients who have received a maximum of one prior chemotherapy for metastatic disease.
  • Prior anticancer therapy should have been interrupted 28 days before the start of study treatment (the patient may have continued treatment with prednisone 5 mg bid.
  • Adequate blood, liver and kidney function:
  • Hemoglobin > 9.0 g/dl
  • ANC > 1.5 x 10*9/L
  • Platelets > 100 x 10*9/L
  • AST/SGOT and ALT/SGPT < 2.5 x ULN
  • Bilirubin < 1.0 x ULN
  • Creatinine <1.5 mg/dL x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded (see Annex 7 for formula)
  • Adequate baseline cardiac function (LVEF ≥ 50%).
  • Life expectancy ≥ 12 weeks.
  • Patients must agree to use an effective contraceptive method during treatment with the study drug and up to 1 month after ending the treatment.

Who cannot join

  • Patients who received radiation therapy that exceeded 40% of the bone marrow reserve or that ended within the last 3 weeks prior to inclusion.
  • If being treated with radiation therapy, should be completed before the three weeks prior to initiation of treatment research.
  • Previous treatment with two or more chemotherapy regimens for metastatic disease. A new line of treatment is also when a patient receives again docetaxel after clinical, radiological or PSA progression to a prior regimen with docetaxel.
  • Previous treatment with chemotherapy or surgery in the last 4 weeks.
  • Peripheral neuropathy or stomatitis ≥ 2 (National Cancer Institute Common Terminology Criteria - NCI CTCAE vs. 4.03).
  • Any other type of cancer in the last 5 years, except for basal cell skin carcinoma.
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  • Cerebral or leptomeningeal metastasis.
  • Myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass, congestive heart failure (NYHA class III or IV), stroke or transitory ischemic episodes.
  • Patients who present any severe or uncontrolled medical condition (including uncontrolled diabetes mellitus) or any other condition that may affect the patient's participation and study compliance.
  • Previous treatment with cabazitaxel.
  • Known hypersensitivity (≥ grade 3)to cabazitaxel, polysorbate 80, prednisone or prednisolone, or docetaxel or paclitaxel.
  • Known history of active infection that requires systemic antibiotic or antifungal treatment.
  • Patients who are receiving or expect to receive treatment with strong inhibitors or strong inducers of cytochrome CYP450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Annexes 5 and 6).
  • Patients being treated with any investigational product.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Spain12 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Institut Català D'Oncologia L'Hospitalet (Ico)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital de Sant Joan de Déu

    Manresa, Barcelona, 08243

  • Complejo Hospitalario de Ourense

    Ourense, 32005

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

  • Hospital Virgen Del Rocío

    Seville, 41013

  • Hospital Nuestra Señora de Valme

    Seville, 41014

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

About this study

Official title: Phase II Study of Weekly Cabazitaxel for Advanced Prostate Cancer in "Unfit" Hormone-Refractory Patients Previously Treated With Docetaxel

This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with Docetaxel.

The purpose of this study is to evaluate the activity of the weekly administration of cabazitaxel as time to progression by PSA at week 12.

Read the detailed description

The efficacy of three-weekly cabazitaxel is accompanied by an appreciable rate of serious side effects and toxic deaths. The toxicity rates observed, including grade III-IV neutropenia, febrile neutropenia and diarrhea, could be an obstacle to the use and management of a drug that, on the other hand, has demonstrated great activity. In the treatment of patients with prostate cancer, who have a larger number of morbidities than patients with breast cancer, we assume the risk that in the transition from clinical trial to clinical practice the drug will not be used much because of the risk of side effects, cost, the discomfort derived from the routine use of G-CSF and the lack of patient compliance with this type of regimens.

Rates of neuropathy, nail and conjunctive toxicity with this new taxane are not relevant, which suggests that weekly administration will not produce relevant toxicity problems. Weekly administration of other taxanes improved hematologic tolerance along with a better therapeutic range in some cases, increasing the dose intensity and activity without increasing the associated toxicity.

Phase I study has been reported studying weekly administration of cabazitaxel, recommended dose is 10 mg/m2, administered on days 1, 8, 15 and 22 every 5 weeks in a 1-hour infusion, being diarrhea the dose-limiting toxicity observed in this study.

Given the pharmacokinetic characteristics of this taxane and its activity and toxicity profile, cabazitaxel might be a good candidate for studying in a weekly administration regimen in patients with prostate cancer with a greater risk of toxicity associated with treatment every 3 weeks, such as patients who have received previous pelvic radiation therapy that affects more than 25% of the bone marrow reserve, patients over 75 years with a worse performance status (ECOG 2) or who have already experienced important hematologic toxicity in the previous treatment with docetaxel.

Being tested
Cabazitaxel 10 mg/m2
Keywords
Weekly cabazitaxel., Advanced Hormone-refractory prostate Cancer., Unfit patients.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cabazitaxel 10 mg/m2Drug

    Also called Jevtana

    Cabazitaxel 10 mg/m2 in a 1-hour infusion on days 1, 8, 15 and 22 of 5-week cycles.

Study groups in NCT01518283
Study groupRoleWhat they receive
CabazitaxelExperimentalDrug: Cabazitaxel 10 mg/m2
Receives: Drug: Cabazitaxel 10 mg/m2

What is being measured

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

  1. Time to progression by PSA at week 12, according to the PCCTWG II criteria.

    Time to progression by PSA at week 12. PSA progression defined as an increase of ≥25% over nadir PSA concentration provided that the increase in the absolute PSA value was ≥5 μg/L for men with no PSA response, or ≥50% over nadir for PSA responders and PSA responders defined as a reduction in serum PSA concentration of ≥50% in patients with a baseline value of ≥20 μg/L.

    Measured: 12 weeks

Secondary outcomes (9)

  1. time to PSA progression

    Time to PSA progression, according to the PCCTWG II criteria, defined as the time between enrolment and the first date of PSA progression.

    Measured: Patients will be followed until PSA progression, an expected average of 6 months

  2. biochemical response rate

    Biochemical response by PSA determination defined as the percentage of patients with 30%,50% and 80% reduction respect to baseline in patients with a baseline value >=20 mcg/L confirmed by a repeat PSA measurement after at least 3 weeks.

    Measured: Patients will be followed until end of treatment, an expected average of 6 months

  3. Objective response rate

    Proportion of patients with an objective tumoral response according to modified RECIST criteria

    Measured: Patients will be followed until end of treatment, an expected average of 6 months

  4. Overall survival

    Overall survival is calculated since the date of patient study enrolment till death.

    Measured: Patients will be followed until death, an expected average of 18 months

  5. Evaluate the safety and tolerability profile of cabazitaxel.

    All adverse events will be graded according to National Cancer Institute Common Terminology Criteria for adverse events (version 4.03).

    Adverse events, biochemistry, hematology, vital signs and electrocardiograms will be monitored throughout the study.

    Measured: 6 months (during treatment)

  6. Pain response

    Determine the pain response in patients with stable pain at baseline by means of the McGill-Melzack MPQ-sf questionnaire, defined as ≥ 2 points with respect to baseline on the PPI scale without increase in the analgesic scale, or with a decrease of ≥ 50% in the use of analgesics without an increase in pain that is maintained for more than 3 weeks.

    Measured: Until end of treatment, an expected average of 6 months

  7. Correlation between presence-absence of baseline pain with overall survival, time to progression and PSA response rate.

    Measured: Until death, an expected average of 18 months

  8. Correlation of the Charlson co-morbidity index and ADL/IADL dependency indexes with survival and toxicity

    Measured: Until death, an expected average of 18 months

  9. Assessment and quantification of Circulating Tumour Cells and level correlation between the beginning of treatment and their variation through treatment with time to progression and overall survival

    Measured: Until death, an expected average of 18 months

Timeline

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

  1. First posted25 Jan 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionJun 2016
  4. Study completionJul 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01518283
Sponsor's protocol ID
CABASEM-SOGUG
Status last verified
Nov 2015
First submitted
17 Jan 2012
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabazitaxel 10 mg/m2 in people with Hormone Refractory Prostate Cancer, run by Spanish Oncology Genito-Urinary Group at 12 sites in Spain.

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 26 inclusion and 14 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Spain. 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?

Time to progression by PSA at week 12, according to the PCCTWG II criteria. (time frame: 12 weeks). 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 NCT01518283.

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 2 Jul 2017.

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