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Clinical Trials/EUCTR2012-002179-32-GR
EUCTR2012-002179-32-GR
Active, not recruiting
Not Applicable

A Multicenter, Phase II, Single-Arm Clinical Trial of nab-Paclitaxel as salvage treatment for patients with Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal junction - N/A

Hellenic Oncology Research Group (H.O.R.G.)0 sitesAugust 8, 2012
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ConditionsPatients with Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal junctionTherapeutic area: Diseases [C] - Cancer [C04]
DrugsPaclitaxel Albumin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients with Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal junction
Sponsor
Hellenic Oncology Research Group (H.O.R.G.)
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 8, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Hellenic Oncology Research Group (H.O.R.G.)

Eligibility Criteria

Inclusion Criteria

  • •Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
  • •Age \> 18 years old
  • •Assessable target lesion(s) as defined by RECIST criteria v1\.1
  • •Disease progression after treatment with the DCF regimen
  • •ECOG performance status \= 1
  • •Hgb \= 8g/dL, WBC \= 3 x 109/L , neutrophils count \= 1\.5 x 109/L , platelets \=100 x 109/L
  • •Creatinine clearance \=50 mL/min
  • •Total bilirubin \= 1\.5 X UNL
  • •AST, ALT and ALP \= 2\.5 x UNL
  • •Estimated life expectancy more than 3 months

Exclusion Criteria

  • •Gastrointestinal bleeding
  • •Clinically relevant, symptomatic excessive amounts of ascites resulting in patient’s discomfort
  • •CNS metastases
  • •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  • •Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
  • •Known hypersensitivity reaction to the component of the treatment.
  • •Active infection or malnutrition or bowel obstruction.
  • •Legal incapacity or limited legal capacity
  • •Definite contraindications for the use of corticosteroids
  • •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.

Outcomes

Primary Outcomes

Not specified

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