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

July 29, 2014 updated by: Rafael Lopez Lopez, Hospital Clinico Universitario de Santiago

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain
        • Hospital German Trias i Pujol
      • Lérida, Spain
        • Hospital Arnau de Vilanova
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Málaga, Spain
        • Hospital Carlos Haya
      • Orense, Spain
        • CHU de Orense
      • Santiago de Compostela, Spain
        • Hospital Clínico de Santiago
      • Valencia, Spain
        • Hospital General de Valencia
      • Zaragoza, Spain
        • Hospital Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Cabazitaxel
Other Names:
  • Jevtana
Other: Best Supportive Care
Best Supportive Care (BSC), with evaluations every 3 weeks (1 cycle).
Other: Best Supportive Care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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.
Time Frame: From date of randomization to disease progression or until 24 months from enrolment
From date of randomization to disease progression or until 24 months from enrolment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: From randomisation to either documented disease progression or death from any cause or until 24 months from enrolment (whichever occurs earlier)
From randomisation to either documented disease progression or death from any cause or until 24 months from enrolment (whichever occurs earlier)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: From date of randomization to death from any cause or until 24 months from enrolment
From date of randomization to death from any cause or until 24 months from enrolment
Safety and toxicity in the experimental arm. Toxicity is graded according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE, v 4.0).
Time Frame: From the date the informed consent is signed up to 30 days after the last dose
From the date the informed consent is signed up to 30 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Clinico Universitario de Santiago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundación Ramón Domínguez

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rafael López López, MD, PhD, Hospital Clínico de Santiago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RLL-CAB-2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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