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Completed

NCT Number: NCT01956149

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

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Krankenhaus Dresden Friedrichstadt, Dresden, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cabazitaxel

Drug

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

Primary outcomes

  1. Disease Control Rate (DCR)

    Time frame: up to 17 months

    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)

Secondary outcomes

  1. Overall survival (OS)

    Time frame: up to 17 months

    From date of randomization until the date of death from any cause, assessed up to 17 months

  2. Progression-free survival (PFS)

    Time frame: up to 17 months

    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

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

    Time frame: up to 17 months

    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)

  4. Toxicity

    Time frame: up to 18 weeks

    incidence and intensity of adverse events

  5. Correlation of circulating tumor cells with PFS and OS

    Time frame: up to 18 weeks

    samples for analysis of circulating tumor cells are taken before therapy, before every new cycle, and at the end of treatment (every 3 weeks).

  6. Correlation of circulating tumor cells with the clinical response

    Time frame: up to 18 weeks

Sponsors and collaborators

Lead sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Oct 8, 2013
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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