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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956149
• Other study ID #: CabaGast
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2013
• Last updated: April 17, 2018
• Start date: September 2013
• Est. completion date: April 4, 2018

Study information

• Verified date: January 2018
• Source: IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 4, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Krankenhaus Dresden Friedrichstadt	Dresden
Germany	Krankenhaus Nordwest	Frankfurt am Main
Germany	Universitätsklinikum Jena	Jena

Sponsors (1)

Lead Sponsor	Collaborator
IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

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