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

NCT ID: NCT02204332

Last Updated: 2014-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cabazitaxel

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.

Group Type EXPERIMENTAL

Cabazitaxel

Intervention Type DRUG

Best Supportive Care

Best Supportive Care (BSC), with evaluations every 3 weeks (1 cycle).

Group Type OTHER

Best Supportive Care

Intervention Type OTHER

Interventions

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Cabazitaxel

Intervention Type DRUG

Best Supportive Care

Intervention Type OTHER

Other Intervention Names

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Jevtana

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Ramón Domínguez

OTHER

Sponsor Role collaborator

Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role lead

Responsible Party

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Rafael Lopez Lopez

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael López López, MD, PhD

Role: STUDY_CHAIR

Hospital Clinico de Santiago

Locations

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Hospital German Trias i Pujol

Badalona, , Spain

Site Status

Hospital Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Carlos Haya

Málaga, , Spain

Site Status

CHU de Orense

Ourense, , Spain

Site Status

Hospital Clinico de Santiago

Santiago de Compostela, , Spain

Site Status

Hospital General de Valencia

Valencia, , Spain

Site Status

Hospital Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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RLL-CAB-2011-01

Identifier Type: -

Identifier Source: org_study_id

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