Clinical trial NCT02204332: Phase II-b Randomized Clinical Trial of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment
Official title: Phase II-b Randomized Study of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
Collaborators: name: Fundación Ramón Domínguez
First posted: 2014-07-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: From date of randomization to disease progression or until 24 months from enrolment
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From randomisation to either documented disease progression or death from any cause or until 24 months from enrolment (whichever occurs earlier)
Other outcomes:
measure: Overall survival (OS)
timeFrame: From date of randomization to death from any cause or until 24 months from enrolment
measure: Safety and toxicity in the experimental arm. Toxicity is graded according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE, v 4.0).
timeFrame: From the date the informed consent is signed up to 30 days after the last dose
Locations:
city: Badalona
country: Spain
facility: Hospital German Trias i Pujol
city: Lérida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Orense
country: Spain
facility: CHU de Orense
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico de Santiago
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Clinico de Santiago
name: Rafael López López, MD, PhD
role: STUDY_CHAIR
References: