Study of Weekly Cabazitaxel for Advanced Prostate Cancer

NCT01518283 | Completed Phase 2

• 1 other identifier: CABASEM-SOGUG
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Hormone Refractory Prostate Cancer

Keywords

Weekly cabazitaxel.; Advanced Hormone-refractory prostate Cancer.; Unfit patients.

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (9)

• time to PSA progression

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

• biochemical response rate

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

• Objective response rate

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

• Overall survival

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

• Evaluate the safety and tolerability profile of cabazitaxel.

  6 months (during treatment)

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

Drug: Cabazitaxel 10 mg/m2

Drug: Cabazitaxel 10 mg/m2

Interventions

Cabazitaxel 10 mg/m2 DRUG

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

Also known as: Jevtana

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• "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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead

Study Sites (12)

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Institut Català D'Oncologia L'Hospitalet (Ico)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital de Sant Joan de Déu

Manresa, Barcelona, 08243, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Complejo Hospitalario de Ourense

Ourense, 32005, Spain

Location

Hospital Virgen Del Rocío

Seville, 41013, Spain

Location

Hospital Nuestra Señora de Valme

Seville, 41014, Spain

Location

Fundación Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Consorcio Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

MeSH Terms

Interventions

cabazitaxel

Study Officials

• Miguel A Climent, MD

  FUNDACIÓN INSTITUTO VALENCIANO DE ONCOLOGÍA, Servicio de Oncología Médica, Profesor Beltrán Báguena, 11, 8 y 19, Valencia, 46009

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 25, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 2, 2017

Record last verified: 2015-11

Locations

ES (12)