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

NCT02166658 | Terminated Phase 2 DMC

• 3 other identifiers: AIO-ZNS-01132013-005545-37CABAZL06457
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Patients with breast or lung cancer and recurrent or progressive brain; metastases

Outcome Measures

Primary Outcomes (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))

  approx. 12 month

Secondary Outcomes (7)

• Overall Survival

  approx. 12 month

• Progression free-survival for brain metastases

  approx. 12 month

• progression-free survival for extracerebral tumor disease

  approx. 12 month

• Time to treatment failure of brain metastases

  12 month

• Quality of life

  approx. 12 month

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: Cabazitaxel

Interventions

Cabazitaxel 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.

Also known as: XRP6258, RPR116258A

Single Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Prior chemotherapy or targeted therapy (e.g. erlotinib, bevacizumab) for brain metastases
• Time interval to prior external beam radiotherapy less than 2 weeks
• Suspected or known leptomeningeal disease
• Peripheral neuropathy ≥ grade 2
• 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)

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• ClinAssess GmbH: collaborator
• Sanofi: collaborator

Study Sites (1)

Kliniken Nordoberpfalz, AG Klinikum Weiden, Medizinische Kliniken I

Weiden, Bavaria, 92637, Germany

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Brain Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

cabazitaxel; XRP6258

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Frank Kullmann, Prof. Dr.

  Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Kliniken I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 18, 2014
• Study Start: August 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: January 18, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

DE (1)