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Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cabazitaxel
Sponsored by
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, second-line treatment, Cabazitaxel, response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach
  2. Progression of a measurable lesion (RECIST) on previous palliative chemotherapy. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs < 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line.
  3. Male and female patients aged > 18 years
  4. ECOG ≤ 1
  5. neutrophils ≥ 1500/µl
  6. Haemoglobin ≥ 9 g/dl
  7. Platelets ≥ 100,000/µl
  8. AST/SGOT and/or ALT/SGPT ≤2.5 x ULN;
  9. Total bilirubin ≤1.0 x ULN
  10. Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min
  11. Written patient informed consent

Exclusion Criteria:

  1. A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3)
  2. Active CAD, cardiomyopathy or NYHA stage III-IV heart failure
  3. Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)
  4. Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection
  5. Concomitant medication or planned treatment with strong CYP450 3A4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment
  6. Peripheral polyneuropathy > NCI grade II
  7. Severe hepatic impairment (AST/ALT > 2.5 x ULN, , bilirubin > 1 x ULN)
  8. Chronic inflammatory bowel disease
  9. Participation in another study
  10. Pregnancy or lactation

Sites / Locations

  • Krankenhaus Dresden Friedrichstadt
  • Krankenhaus Nordwest
  • Universitätsklinikum Jena

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cabazitaxel

Arm Description

Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22

Outcomes

Primary Outcome Measures

Disease Control Rate (DCR)
Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)

Secondary Outcome Measures

Overall survival (OS)
From date of randomization until the date of death from any cause, assessed up to 17 months
Progression-free survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 17 months
Response rate by subgroup (with and without previous treatment with a taxane)
Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)
Toxicity
incidence and intensity of adverse events
Correlation of circulating tumor cells with PFS and OS
samples for analysis of circulating tumor cells are taken before therapy, before every new cycle, and at the end of treatment (every 3 weeks).
Correlation of circulating tumor cells with the clinical response

Full Information

First Posted
July 3, 2013
Last Updated
April 17, 2018
Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
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1. Study Identification

Unique Protocol Identification Number
NCT01956149
Brief Title
Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer
Official Title
Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.
Detailed Description
65 patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach will be treated with 20mg/m2 Cabazitaxel for a maximum of 6 cycles. Main objective of the study is the Disease Control Rate (DCR) with Cabazitaxel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, second-line treatment, Cabazitaxel, response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cabazitaxel
Arm Type
Experimental
Arm Description
Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22
Intervention Type
Drug
Intervention Name(s)
Cabazitaxel
Intervention Description
20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.
Primary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)
Time Frame
up to 17 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
From date of randomization until the date of death from any cause, assessed up to 17 months
Time Frame
up to 17 months
Title
Progression-free survival (PFS)
Description
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 17 months
Time Frame
up to 17 months
Title
Response rate by subgroup (with and without previous treatment with a taxane)
Description
Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)
Time Frame
up to 17 months
Title
Toxicity
Description
incidence and intensity of adverse events
Time Frame
up to 18 weeks
Title
Correlation of circulating tumor cells with PFS and OS
Description
samples for analysis of circulating tumor cells are taken before therapy, before every new cycle, and at the end of treatment (every 3 weeks).
Time Frame
up to 18 weeks
Title
Correlation of circulating tumor cells with the clinical response
Time Frame
up to 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach Progression of a measurable lesion (RECIST) on previous palliative chemotherapy. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs < 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line. Male and female patients aged > 18 years ECOG ≤ 1 neutrophils ≥ 1500/µl Haemoglobin ≥ 9 g/dl Platelets ≥ 100,000/µl AST/SGOT and/or ALT/SGPT ≤2.5 x ULN; Total bilirubin ≤1.0 x ULN Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min Written patient informed consent Exclusion Criteria: A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3) Active CAD, cardiomyopathy or NYHA stage III-IV heart failure Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin) Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection Concomitant medication or planned treatment with strong CYP450 3A4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment Peripheral polyneuropathy > NCI grade II Severe hepatic impairment (AST/ALT > 2.5 x ULN, , bilirubin > 1 x ULN) Chronic inflammatory bowel disease Participation in another study Pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Schmalenberg, MD
Organizational Affiliation
Krankenhaus Dresden Friedrichstadt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus Dresden Friedrichstadt
City
Dresden
Country
Germany
Facility Name
Krankenhaus Nordwest
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany

12. IPD Sharing Statement

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Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer

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