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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204332
Recruitment Status : Terminated (Interim analysis performed on the first 10 patients showed no efficacy of cabazitaxel)
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
Sponsor:
Collaborator:
Fundación Ramón Domínguez
Information provided by (Responsible Party):
Rafael Lopez Lopez, Hospital Clinico Universitario de Santiago

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Cabazitaxel Other: Best Supportive Care Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II-b Randomized Study of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment
Study Start Date : March 2013
Actual Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel

Arm Intervention/treatment
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 Name: Jevtana

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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) ]

Other Outcome Measures:
  1. Overall survival (OS) [ Time Frame: From date of randomization to death from any cause or until 24 months from enrolment ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204332


Locations
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Spain
Hospital German Trias i Pujol
Badalona, Spain
Hospital Arnau de Vilanova
Lérida, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Carlos Haya
Málaga, Spain
CHU de Orense
Orense, Spain
Hospital Clinico de Santiago
Santiago de Compostela, Spain
Hospital General de Valencia
Valencia, Spain
Hospital Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Hospital Clinico Universitario de Santiago
Fundación Ramón Domínguez
Investigators
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Study Chair: Rafael López López, MD, PhD Hospital Clinico de Santiago

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Responsible Party: Rafael Lopez Lopez, MD,PhD, Hospital Clinico Universitario de Santiago
ClinicalTrials.gov Identifier: NCT02204332    
Other Study ID Numbers: RLL-CAB-2011-01
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases