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

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Cabazitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01956149

CabaGast

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Cabazitaxel

Experimental group

Description:

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

Treatment:

Drug: Cabazitaxel