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

NCT02204332 | Terminated Phase 2

• 1 other identifier: RLL-CAB-2011-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 8

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (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.

  From date of randomization to disease progression or until 24 months from enrolment

Secondary Outcomes (1)

• 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)

Other Outcomes (2)

• Overall survival (OS)

  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).

  From the date the informed consent is signed up to 30 days after the last dose

Study Arms (2)

Cabazitaxel

EXPERIMENTAL

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

Best Supportive Care

OTHER

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

Other: Best Supportive Care

Interventions

Cabazitaxel DRUG

Also known as: Jevtana

Cabazitaxel

Best Supportive Care OTHER

Best Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• Fundación Ramón Domínguez: collaborator

Study Sites (8)

Hospital German Trias i Pujol

Badalona, Spain

Location

Hospital Arnau de Vilanova

Lleida, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Carlos Haya

Málaga, Spain

Location

CHU de Orense

Ourense, Spain

Location

Hospital Clinico de Santiago

Santiago de Compostela, Spain

Location

Hospital General de Valencia

Valencia, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rafael López López, MD, PhD

  Hospital Clinico de Santiago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 30, 2014
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

ES (8)