Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer

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.

The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction

Study Overview

• Status: Completed
• Conditions: Stomach and Gastro-Esophageal Junction (GEJ) Cancer
• Intervention / Treatment: Drug: nab-Paclitaxel

Detailed Description

Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. The promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage treatment for patients with advanced cancer of the stomach and GEJ previously treated with the DCF regimen.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
  • Athens, Greece
    • Air Forces Military Hospital of Athens Athens, Greece
  • Athens, Greece
    • SOTIRIA Hospital, Medical Oncology Department
  • Chania, Greece
    • "Ag. Georgios" General Hospital of Chania
  • Thessaloniki, Greece
    • "PAPAGEORGIOY" General Hospital of Thessaloniki
  • Crete
    • Heraklion, Crete, Greece
      • University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18 years old
• Disease progression after treatment with the DCF regimen
• Assessable target lesion(s) as defined by RECIST criteria
• ECOG performance status ≤ 1
• Estimated life expectancy more than 3 months
• Serum bilirubin less than 1.5 times the upper normal limit
• Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit
• Creatinine Clearance ≥50 ml/min
• Neutrophil count more than 1.5x 109 /L
• Platelet count more than 100x 109 /L
• Hemoglobin more than 8g/dL
• Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.

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
• Chronic inflammation of the bowel
• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
• Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
• Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nab-Paclitaxel; Abraxane	Drug: nab-Paclitaxel; Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d); Other Names: Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate	Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response	Disease evaluation every 8 weeks up to 108 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate	Documented disease control rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response	Disease evaluation every 8 weeks up to 108 weeks
Progression Free Survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 108 weeks	Up to 108 weeks
Overall Survival	From date of randomization until the date of last follow up or death from any cause, assessed up to 108 weeks	Up to 108 weeks
Number of Participants with Adverse Events		Every two weeks up to 24 weeks

Collaborators and Investigators

• Sponsor: Hellenic Oncology Research Group
• Investigators: Principal Investigator: John Souglakos, MD, University Hospital of Herklion; Principal Investigator: Vassilis Georgoulias, MD, University Hospital of Heraklion

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 5, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Cancer; Stomach; Nab-paclitaxel; Salvage treatment; Gastro-Esophageal Junction
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: CT/12.05