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

Phase 2

Terminated

• Conditions: Colorectal Cancer
• Interventions: Other: Best Supportive Care; Drug: Cabazitaxel

• Registration Number: NCT02204332
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-29
• Last Update Submitted: 2014-07-29
• Study First Posted: 2014-07-30
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best Supportive Care	Best Supportive Care	Best Supportive Care (BSC), with evaluations every 3 weeks (1 cycle).
Cabazitaxel	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (8)

Hospital General de Valencia; 🇪🇸 Valencia, Spain

Hospital Clinico de Santiago; 🇪🇸 Santiago de Compostela, Spain

Hospital Arnau de Vilanova; 🇪🇸 Lérida, Spain

Hospital German Trias i Pujol; 🇪🇸 Badalona, Spain

CHU de Orense; 🇪🇸 Orense, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Carlos Haya; 🇪🇸 Málaga, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain