Back to results

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

Primary Purpose

Metastatic Castration Resistant Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Cabazitaxel

weekly cabazitaxel

About this trial

This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer focused on measuring Prostate Cancer, Metastatic, Castration Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:¨

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

Exclusion Criteria:

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.
Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic radiotherapy is not an exclusion criteria)
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,
- infectious or inflammatory bowel disease,
- pulmonary embolism
- Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
History of hypersensitivity to docetaxel or polysorbate 80
Inadequate organ and bone marrow function as evidenced by:
- Hemoglobin < 9.0 g/dL
- Absolute neutrophil count < 1.5 x 109/L,
- Platelet count < 100 x 109/L,
- AST/SGOT and/or ALT/SGPT > 1.5 x ULN;
- Total bilirubin > 1.0 x ULN,
- Serum creatinine > 1.5 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 (http://mdrd.com/ for on-line calculation)
Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5. A one week wash out period is necessary for patients who are already on these treatments.
Patients with reproductive potential not implementing accepted and effective method of contraception.

Sites / Locations

Deapartment of Oncology Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Cabazitaxel Schedule

Weekly cabazitaxel schedule

Arm Description

Cabazitaxel 25 mg/m2 every three weeks

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival

Overall survival is defined as the length of time from randomization to death from any cause

Progression free survival

Progression free survival is defined as the length of time from randomisation to the first documentation of one of the following: PSA progression or pain progression or death due to any cause or radiological disease progression

PSA Response

Only considered after 12 weeks of treatment. PSA response is defined as a 50% or greater decline in serum PSA from baseline given that baseline PSA is at least 10 ng/ml

Full Information

NCT ID

NCT01541007

First Posted

February 23, 2012

Last Updated

October 30, 2015

Sponsor

Jeffrey Yachnin M.D., PhD.

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01541007

Brief Title

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

Acronym

ConCab

Official Title

A Randomized, Open Label, Multicenter, Phase II Trial Comparing The Conventional 3 Weekly Schedule Of Cabazitaxel With A Weekly Regimen In Patients With Metastatic Castration Resistant Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jeffrey Yachnin M.D., PhD.

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

ConCab compares the standard treatment of cabazitaxel 25 mg/m2 every three weeks with an experimental scheduling of 10 mg/m2 for 5 consecutive weeks of a 6 week cycle. In both study arms the planned cumulative dose of cabazitaxel at week 18 is 150 mg/m2. Our study aims to evaluate differences in the total received dose in relation to the planned dose as a measure of which of the 2 treatment schedules is superior.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Castration Resistant Prostate Cancer

Keywords

Prostate Cancer, Metastatic, Castration Resistant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Cabazitaxel Schedule

Arm Type

Active Comparator

Arm Description

Cabazitaxel 25 mg/m2 every three weeks

Arm Title

Weekly cabazitaxel schedule

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cabazitaxel

Intervention Description

25 mg/m2 every three weeks

Intervention Type

Drug

Intervention Name(s)

weekly cabazitaxel

Intervention Description

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

Primary Outcome Measure Information:

Title

Relative cumulative dose of cabazitaxel at week 18

Description

Time Frame

week 18 after start of treatment

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival is defined as the length of time from randomization to death from any cause

Time Frame

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

Title

Progression free survival

Description

Time Frame

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

Title

PSA Response

Description

Only considered after 12 weeks of treatment. PSA response is defined as a 50% or greater decline in serum PSA from baseline given that baseline PSA is at least 10 ng/ml

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:¨ 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 Exclusion Criteria: 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. Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic radiotherapy is not an exclusion criteria) 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, infectious or inflammatory bowel disease, pulmonary embolism Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results History of hypersensitivity to docetaxel or polysorbate 80 Inadequate organ and bone marrow function as evidenced by: Hemoglobin < 9.0 g/dL Absolute neutrophil count < 1.5 x 109/L, Platelet count < 100 x 109/L, AST/SGOT and/or ALT/SGPT > 1.5 x ULN; Total bilirubin > 1.0 x ULN, Serum creatinine > 1.5 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 (http://mdrd.com/ for on-line calculation) Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5. A one week wash out period is necessary for patients who are already on these treatments. Patients with reproductive potential not implementing accepted and effective method of contraception.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey R Yachnin, MD, PhD

Organizational Affiliation

Karolinska University Hosptial

Official's Role

Study Chair

Facility Information:

Facility Name

Deapartment of Oncology Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs