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

Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach

Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Cabazitaxel

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany
    • Krankenhaus Dresden Friedrichstadt
  • Frankfurt am Main, Germany, 60488
    • Krankenhaus Nordwest
  • Jena, Germany, 07747
    • Universitatsklinikum Jena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	up to 17 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	From date of randomization until the date of death from any cause, assessed up to 17 months	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	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)	up to 17 months
Toxicity	incidence and intensity of adverse events	up to 18 weeks
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).	up to 18 weeks
Correlation of circulating tumor cells with the clinical response		up to 18 weeks

Collaborators and Investigators

• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Investigators: Principal Investigator: Harald Schmalenberg, MD, Krankenhaus Dresden Friedrichstadt

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): April 4, 2018

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: October 1, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: response; gastric cancer; Cabazitaxel; second-line treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: CabaGast