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Breast CancerPhase 2CaBaMetNCT02166658

A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)

A Phase 2 study testing Cabazitaxel in people with Breast Cancer and Lung Cancer, run by AIO-Studien-gGmbH at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Patients suffering from histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases after prior external beam radiotherapy will receive treatment with cabazitaxel until progression of brain metastases (BM) or unacceptable toxicity. Read more about this study

Who is it for?
Ages 18 years and older
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
8 participants
Where
1 siteGermany
Study dates
Aug 2015to 18 Jan 2018
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

  • Adult patients (≥ 18 years of age)
  • Histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Prior external beam radiotherapy (WBRT or SRS) of BM Patients suffering from small cell lung cancer (SCLC) who have been treated with chemotherapy and prophylactic cranial radiotherapy may be also enrolled.
  • At least one two-dimensional measurable lesion on brain MRI
  • Life expectancy at least 3 months
  • Females of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of the first application of study treatment and must agree to use effective contraceptive birth control measures (Pearl Index < 1) during the course of the Trial. A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 year, or unless she is surgically sterile.
  • Males must agree to use effective contraception (Pearl Index < 1) during the course of the trial and for at least 6 months after last administration of study medication cabazitaxel. In addition males must agree to prevent contact with the ejaculate by another person throughout study treatment.

Who cannot join

  • Prior chemotherapy or targeted therapy (e.g. erlotinib, bevacizumab) for brain metastases
  • Any chemotherapy or targeted tumor therapy within two weeks of study inclusion or concomitantly
  • Any antihormonal tumor treatment within two weeks of study inclusion or concomitantly
  • Time interval to prior external beam radiotherapy less than 2 weeks
  • Suspected or known leptomeningeal disease
  • Peripheral neuropathy ≥ grade 2
Show all 22Show fewer
  • Inadequate organ and bone marrow function as evidenced by:
  • Absolute neutrophil count (ANC) < 1.5 x 10*9/L;
  • Hemoglobin < 10.0 g/dL;
  • Platelet count < 100 x 10*9/L;
  • Total bilirubin ≥ 1 x upper limit of normal (ULN);
  • AST/GOT and/or ALT/GPT ≥ 1.5 x ULN;
  • Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN; creatinine clearance has to be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and patients with creatinine clearance < 60 mL/min must be excluded
  • Other inadequate organ function according to investigator's discretion
  • History of hypersensitivity reaction to docetaxel
  • History of hypersensitivity reaction to polysorbate 80 containing drugs
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week washout period is necessary for patients who are already on these treatments; see also Section 10 and Appendix 3 and 4; dexamethasone is allowed)
  • Recently received or planned vaccination against yellow fever during study treatment
  • Pregnant or breast feeding females
  • Participation in any other clinical trial or treatment with any experimental drug within 28 day before enrolment to the study or during study participation until the end of treatment visit
  • Previous or concurrent tumor other than underlying tumor disease (breast or lung cancer) with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta,Tis, and T1) or any curatively treated tumors > 5 years prior to enrolment

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Kliniken Nordoberpfalz, AG Klinikum Weiden, Medizinische Kliniken I

    Weiden, Bavaria, 92637

Other trials in Germany

About this study

Official title: A Phase II Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)

Patients suffering from histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases after prior external beam radiotherapy will receive treatment with cabazitaxel until progression of brain metastases (BM) or unacceptable toxicity.

Read the detailed description

Cabazitaxel is a new taxane compound that exhibited a broad spectrum of in vivo antitumor activity, not only in docetaxel - sensitive tumor models, but also in tumors models in which docetaxel was poorly or not active. In contrast to other taxanes, cabazitaxel has the ability to cross the blood-brain-barrier. Marked antitumor activity was obtained in nude mice bearing intracranial glioblastomas. Consequently, there is a good rationale to investigate cabazitaxel in patients with breast or lung cancer and recurrent or progressive brain metastases.

The primary object of the study is to measure objective tumor response of brain metastases for patients with breast or lung cancer and recurrent or progressive brain metastases.

Being tested
Cabazitaxel
Keywords
Patients with breast or lung cancer and recurrent or progressive brain, metastases
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Brain Neoplasms, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabazitaxelDrug

    Also called XRP6258, RPR116258A

    Cabazitaxel 25 mg/m2 i.v. infusion (infusion time about 1h) on D1 of each 21-day cycle. Continuation of treatment until progression of brain metastases or unacceptable toxicity.

Study groups in NCT02166658
Study groupRoleWhat they receive
Single ArmExperimentalPatients receive Cabazitaxel 25 mg/m2 i.v. infusion. This trial is a single arm trial.
Receives: Drug: Cabazitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective tumor response of brain metastases

    Objective tumor response of brain metastases (Complete response (CR) or partial response (PR) or at least a minor response (MR; 25-50% reduction) according to WHO criteria1,2 and Iwamoto3 confirmed by magnetic resonance imaging (MRI))

    Measured: approx. 12 month

Secondary outcomes (7)

  1. Overall Survival

    Efficacy measure

    Measured: approx. 12 month

  2. Progression free-survival for brain metastases

    Efficacy measure

    Measured: approx. 12 month

  3. progression-free survival for extracerebral tumor disease

    Efficacy measure

    Measured: approx. 12 month

  4. Time to treatment failure of brain metastases

    Efficacy measure

    Measured: 12 month

  5. Quality of life

    Efficacy measure, assessed with EORTC QLQ-C30 and additional module BN20 questionnaire

    Measured: approx. 12 month

  6. Type, incidence and severity of adverse events

    Safety measure

    Measured: approx. 12 month

  7. Dose reduction or discontinuation of study drug cabazitaxel due to adverse events

    Safety measure

    Measured: approx. 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2014 (estimated)
  2. Study startAug 2015
  3. Primary completionApr 2017
  4. Study completion18 Jan 2018

Why it stopped: After a recruitment of more than 2 years, only 8 patients have been registered.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02166658
Sponsor's protocol ID
AIO-ZNS-0113
Other IDs
2013-005545-37, CABAZL06457
Acronym
CaBaMet
Status last verified
Jan 2018
First submitted
16 Jun 2014
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabazitaxel in people with Breast Cancer and Lung Cancer, run by AIO-Studien-gGmbH at 1 site in Germany.

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 8 inclusion and 22 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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: After a recruitment of more than 2 years, only 8 patients have been registered.). 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?

Objective tumor response of brain metastases (time frame: approx. 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02166658.

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 23 Jan 2018.

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