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

NCT ID: NCT01956149

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-04-04

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel

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

Group Type: EXPERIMENTAL

Cabazitaxel

Intervention Type: DRUG

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

Interventions

Cabazitaxel

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harald Schmalenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Dresden Friedrichstadt

Locations

Krankenhaus Dresden Friedrichstadt

Dresden, , Germany

Krankenhaus Nordwest

Frankfurt am Main, , Germany

Universitätsklinikum Jena

Jena, , Germany

Countries

Germany

Other Identifiers

CabaGast

Identifier Type: -

Identifier Source: org_study_id