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

NCT ID: NCT02166658

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-01-18

Brief 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.

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.

Conditions

Breast Cancer; Lung Cancer; Recurrent Brain Metastases; Progressive Brain Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Patients receive Cabazitaxel 25 mg/m2 i.v. infusion. This trial is a single arm trial.

Group Type: EXPERIMENTAL

Cabazitaxel

Intervention Type: DRUG

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.

Interventions

Cabazitaxel

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.

Intervention Type: DRUG

Other Intervention Names

XRP6258, RPR116258A

Eligibility Criteria

Inclusion Criteria

1. Adult patients (≥ 18 years of age)

2. Histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

4. 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.

5. At least one two-dimensional measurable lesion on brain MRI

6. Life expectancy at least 3 months

7. 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.

8. 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.

Exclusion Criteria

1. Prior chemotherapy or targeted therapy (e.g. erlotinib, bevacizumab) for brain metastases

2. Any chemotherapy or targeted tumor therapy within two weeks of study inclusion or concomitantly

3. Any antihormonal tumor treatment within two weeks of study inclusion or concomitantly

4. Time interval to prior external beam radiotherapy less than 2 weeks

5. Suspected or known leptomeningeal disease

6. Peripheral neuropathy ≥ grade 2

7. 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

8. Other inadequate organ function according to investigator's discretion

9. History of hypersensitivity reaction to docetaxel

10. History of hypersensitivity reaction to polysorbate 80 containing drugs

11. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)

12. 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)

13. Recently received or planned vaccination against yellow fever during study treatment

14. Pregnant or breast feeding females

15. 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

16. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinAssess GmbH

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

AIO-Studien-gGmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Kullmann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Kliniken I

Locations

Kliniken Nordoberpfalz, AG Klinikum Weiden, Medizinische Kliniken I

Weiden, Bavaria, Germany

Countries

Germany

Related Links

http://www.aio-portal.de

Working Group for Medical Oncology (AIO) from the German Cancer Society (DKG)

Other Identifiers

2013-005545-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CABAZL06457

Identifier Type: OTHER

Identifier Source: secondary_id

AIO-ZNS-0113

Identifier Type: -

Identifier Source: org_study_id