Colorectal CancerPhase 2COMETANCT02204332
Phase II-b Randomized Clinical Trial of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment
A Phase 2 study testing Cabazitaxel in people with Colorectal Cancer, run by Hospital Clinico Universitario de Santiago at 8 sites in Spain.
Trial summary
The purpose of this study is to determine efficacy and safety of cabazitaxel administration in patients with colorectal cancer resistant to standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cabazitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 8 sitesSpain
- Study dates
- Mar 2013to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital German Trias i Pujol
Badalona
Hospital Arnau de Vilanova
Lleida
Hospital Ramón y Cajal
Madrid
Hospital Carlos Haya
Málaga
CHU de Orense
Ourense
Hospital Clinico de Santiago
Santiago de Compostela
Hospital General de Valencia
Valencia
Hospital Miguel Servet
Zaragoza
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Being tested
- Cabazitaxel, Best Supportive Care
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called Jevtana
Best Supportive CareOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cabazitaxel |
| Best Supportive Care | Other | Best Supportive Care (BSC), with evaluations every 3 weeks (1 cycle). Receives: Other: Best Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization to disease progression or until 24 months from enrolment
Secondary outcomes (1)
Progression-free survival (PFS)
Measured: From randomisation to either documented disease progression or death from any cause or until 24 months from enrolment (whichever occurs earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startMar 2013
- Primary completionSep 2013
Why it stopped: Interim analysis performed on the first 10 patients showed no efficacy of cabazitaxel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Ramón Domínguez
- Responsible party
- Principal investigator, Rafael Lopez Lopez, Hospital Clinico Universitario de Santiago
- Investigators
- Rafael López López, MD, PhD, Study chair, Hospital Clinico de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204332
- Sponsor's protocol ID
- RLL-CAB-2011-01
- Acronym
- COMETA
- Status last verified
- Jul 2014
- First submitted
- 23 Jul 2014
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II-b Randomized Study of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment
- ClinicalTrials.gov ID
- NCT02204332
- Acronym / sponsor ID
- COMETA / RLL-CAB-2011-01
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis performed on the first 10 patients showed no efficacy of cabazitaxel
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Collaborators
- Fundación Ramón Domínguez
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine efficacy and safety of cabazitaxel administration in patients with colorectal cancer resistant to standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: CabazitaxelCabazitaxel 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. |
| Best Supportive Care | Other | Other: Best Supportive CareBest Supportive Care (BSC), with evaluations every 3 weeks (1 cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- Patients with a performance status greater than 2, as Eastern Cooperative Oncology Group (ECOG).
- Inadequate marrow reserve, within 7 days prior to randomization:
- Inadequate liver function within 7 days prior to randomization:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabazitaxelAlso: Jevtana | Drug | Cabazitaxel |
| Best Supportive Care | Other | Best Supportive Care |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study was stopped early (reason given: Interim analysis performed on the first 10 patients showed no efficacy of cabazitaxel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael López López, MD, PhD study chair
Hospital Clinico de Santiago
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel in people with Colorectal Cancer, run by Hospital Clinico Universitario de Santiago at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis performed on the first 10 patients showed no efficacy of cabazitaxel). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From date of randomization to disease progression or until 24 months from enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.