We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    cabagast
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01956149
Recruitment Status : Active, not recruiting
First Posted : October 8, 2013
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Cabazitaxel Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach
Study Start Date : September 2013
Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Cabazitaxel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cabazitaxel
Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22
Drug: Cabazitaxel
20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.


Outcome Measures

Primary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: up to 17 months ]
    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 :
  1. Overall survival (OS) [ Time Frame: up to 17 months ]
    From date of randomization until the date of death from any cause, assessed up to 17 months

  2. Progression-free survival (PFS) [ Time Frame: up to 17 months ]
    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

  3. Response rate by subgroup (with and without previous treatment with a taxane) [ Time Frame: up to 17 months ]
    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)

  4. Toxicity [ Time Frame: up to 18 weeks ]
    incidence and intensity of adverse events

  5. Correlation of circulating tumor cells with PFS and OS [ Time Frame: up to 18 weeks ]
    samples for analysis of circulating tumor cells are taken before therapy, before every new cycle, and at the end of treatment (every 3 weeks).

  6. Correlation of circulating tumor cells with the clinical response [ Time Frame: up to 18 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956149


Locations
Germany
Krankenhaus Dresden Friedrichstadt
Dresden, Germany
Krankenhaus Nordwest
Frankfurt am Main, Germany, 60488
Universitätsklinikum Jena
Jena, Germany, 07747
Sponsors and Collaborators
IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
Investigators
Principal Investigator: Harald Schmalenberg, MD Krankenhaus Dresden Friedrichstadt
More Information

Responsible Party: IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT01956149     History of Changes
Other Study ID Numbers: CabaGast
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest:
gastric cancer
second-line treatment
Cabazitaxel
response

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases