A Study Looking at Novel Scheduling of Cabazitaxel for Patients With Metastatic Prostate Cancer

NCT01541007 | Completed Phase 2 DMC

• 1 other identifier: 2011-004178-27
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost one in 4 patients treated with Cabazitaxel in this study required dose reductions or dose delays or stopped treatment due to toxicity. ConCab examines another scheduling for cabazitaxel to see if we can improve tolerability so that patients will receive a higher percentage of the treatment as planned.

Conditions

Metastatic Castration Resistant Prostate Cancer

Keywords

Prostate Cancer; Metastatic; Castration Resistant

Outcome Measures

Primary Outcomes (1)

• Relative cumulative dose of cabazitaxel at week 18

  The primary endpoint compares the cumulative dose of cabazitaxel that is received relative to the planned dose at 18 weeks of therapy. The cumulative dose of cabazitaxel in relation to the expected dose is a reflection of both tolerability and efficacy. Patients stopping treatment due to disease progression prior to week 18 will have lower relative cumulative doses as will patients with poor tolerability due to dose reductions and delays.

  week 18 after start of treatment

Secondary Outcomes (3)

• Overall Survival

  when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date

• Progression free survival

  when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date

• PSA Response

  when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date

Study Arms (2)

Standard Cabazitaxel Schedule

ACTIVE COMPARATOR

Cabazitaxel 25 mg/m2 every three weeks

Drug: Cabazitaxel

Weekly cabazitaxel schedule

EXPERIMENTAL

cabazitaxel 10 mg/m2 given weekly for 5 consecutive weeks of a six week cycle

Drug: weekly cabazitaxel

Interventions

Cabazitaxel DRUG

25 mg/m2 every three weeks

Standard Cabazitaxel Schedule

weekly cabazitaxel DRUG

10 mg/m2 dag 1,8,15,22. Cycle length is 6 weeks

Weekly cabazitaxel schedule

Eligibility Criteria

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

You may qualify if:

• Histological confirmed prostate cancer
• Macroscopic metastatic disease
• Prior treatment with Docetaxel
• Castration resistant disease defined as:Serum testosterone (\< 0.5 ng/ml) and:
• Increase in measurable disease (RECIST 1.1, see appendix 10) or
• For non-measurable disease, the appearance of at least one new lesion on nuclear scintigraphy) or
• A rising PSA from the previous reference value on 2 consecutive occasions at least one week apart
• Written informed consent

You may not qualify if:

• Less than 21 days since prior treatment with chemotherapy
• Less than 14 days since radiotherapy or surgery to the start of cabazitaxel - Less than 4 weeks after stopping endocrine therapies including antiandrogen, abiraterone or other new agents.
• Persistent adverse events from previous cancer therapies \> grade 1 (CTCAE - Version 4.0) with the exception of alopecia. (With respect to peripheral neuropathy and nail changes grade 2 is acceptable)
• ECOG performance status \> 1
• Known CNS malignancy
• Within 6 months of randomization:
• myocardial infarction,
• unstable angina,
• angioplasty,
• bypass surgery,
• stroke,
• TIA, or
• congestive heart failure NYHA class III or IV
• Within 3 months prior to randomization:
• treatment resistant peptic ulcer disease,

Sponsors & Collaborators

• Jeffrey Yachnin M.D., PhD.: lead
• Sanofi: collaborator

Study Sites (1)

Deapartment of Oncology Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey R Yachnin, MD, PhD

  Karolinska University Hosptial

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Clinical Trials Unit

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 2, 2015

Record last verified: 2015-10

Locations

SE (1)