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

NCT01956149 | Completed Phase 2 DMC

• 1 other identifier: CabaGast
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

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.

Conditions

Gastric Cancer

Keywords

gastric cancer; second-line treatment; Cabazitaxel; response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall survival (OS)

  up to 17 months

• Progression-free survival (PFS)

  up to 17 months

• Response rate by subgroup (with and without previous treatment with a taxane)

  up to 17 months

• Toxicity

  up to 18 weeks

• Correlation of circulating tumor cells with PFS and OS

  up to 18 weeks

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

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

Drug: Cabazitaxel

Interventions

Cabazitaxel DRUG

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

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach
• 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.
• Male and female patients aged \> 18 years
• ECOG ≤ 1
• neutrophils ≥ 1500/µl
• Haemoglobin ≥ 9 g/dl
• Platelets ≥ 100,000/µl
• AST/SGOT and/or ALT/SGPT ≤2.5 x ULN;
• Total bilirubin ≤1.0 x ULN
• Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min
• Written patient informed consent

You may not qualify if:

• A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3)
• Active CAD, cardiomyopathy or NYHA stage III-IV heart failure
• Malignant secondary disease dating back \< 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)
• Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection
• 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
• Peripheral polyneuropathy \> NCI grade II
• Severe hepatic impairment (AST/ALT \> 2.5 x ULN, , bilirubin \> 1 x ULN)
• Chronic inflammatory bowel disease
• Participation in another study
• Pregnancy or lactation

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead

Study Sites (3)

Krankenhaus Dresden Friedrichstadt

Dresden, Germany

Location

Krankenhaus Nordwest

Frankfurt am Main, 60488, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Harald Schmalenberg, MD

  Krankenhaus Dresden Friedrichstadt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: April 4, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-01

Locations

DE (3)