Phase II-b Randomized Clinical Trial of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment

Study Overview
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Brief Summary
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The purpose of this study is to determine efficacy and safety of cabazitaxel administration in patients with colorectal cancer resistant to standard treatment.

Official Title
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Phase II-b Randomized Study of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Cabazitaxel
* Other: Best Supportive Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have given written informed consent. Men and women aged ≥ 18 years. Patients with histologically confirmed metastatic advanced colorectal cancer without the possibility of potentially curative treatment. Patients with a life expectancy more than three months. Patients with advanced colorectal cancer in progression after receiving standard treatment. Patients with grade 0-2 functional status, according to Eastern Cooperative Oncology Group (ECOG). Patients with evaluable tumor by RECIST criteria. Patients recovered and with a degree less than or equal to 1, or baseline of all important pre-treatment-related AEs (excluding alopecia). Ability and willingness of the patient to consent to participation in the study. Ability to understand and comply with study procedures. Exclusion Criteria: Patients with a performance status greater than 2, as Eastern Cooperative Oncology Group (ECOG). Inadequate marrow reserve, within 7 days prior to randomization: absolute neutrophil count <1.5 x 109 / L Hemoglobin <9.0 g / dL Platelet count <100 x 109 / L Inadequate liver function within 7 days prior to randomization: AST (SGOT) and ALT (SGPT)> 3.0 x ULN or 5> x ULN in case of abnormal liver function due to underlying liver metastases. Alkaline phosphatase> 3 × ULN (or 5 times the ULN if due to underlying liver metastases). Total bilirubin> 1.5 x ULN. Previous history of other malignancy, except for skin basal or squamous cell cancer with proper treatment, or in situ cervical cancer, or other cancers, in which the patient has been free of the disease in the last 5 years. Simultaneous treatment with concomitant anticancer therapy. History of brain metastases, uncontrolled compression of spinal cord, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease pathologies. Acquired Immunodeficiency Syndrome (AIDS-related diseases) or human immunodeficiency virus (HIV) or conditions requiring antiretroviral therapy virus. symptomatic grade ≥ 2 peripheral sensory neuropathy, according to NCI-CTCAE v4.0. Any severe acute or chronic medical condition that may affect the patient's ability to participate in the study, or may lead to unacceptable security risks and non-compliance with protocol procedures or may interfere with the interpretation of the study results. Pregnant women or who are breastfeeding. Pregnancy assessment will be conducted by a test serum or urine during the 7 days prior to randomization. Patient (male or female) of reproductive age who still disagrees with the use of effective contraception during the treatment period and for at least 3 months after completion of the treatment period of the study. The definition of effective method of birth control is the opinion of the investigator. Participation in another clinical trial with an investigational drug and / or an investigational drug as adjunctive therapy within 30 days prior to randomization. Concomitant treatment with prohibited drugs as potent inhibitors or inducers of cytochrome P450 3A4.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cabazitaxel<br>Cabazitaxel at a dose of 25 mg / m² in a 5% dextrose or 0.9% NaCl intravenously over 1 hour, every 3 weeks (1 cycle). Besides, patient will be treated with BSC. | Drug: Cabazitaxel<br> <br> * Other names: Jevtana;|
| Other: Best Supportive Care<br>Best Supportive Care (BSC), with evaluations every 3 weeks (1 cycle). | Other: Best Supportive Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of cabazitaxel measured by estimating the overall response rate (ORR), as the percentage of individuals who achieve a complete tumor response (CR) or partial tumor response (PR) in each arm and between arms. |  | From date of randomization to disease progression or until 24 months from enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | From randomisation to either documented disease progression or death from any cause or until 24 months from enrolment (whichever occurs earlier) |