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.
Overview
- Phase
- Phase 2
- Intervention
- nab-Paclitaxel
- Conditions
- Stomach and Gastro-Esophageal Junction (GEJ) Cancer
- Sponsor
- Hellenic Oncology Research Group
- Enrollment
- 39
- Locations
- 6
- Primary Endpoint
- Overall Response Rate
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
nab-Paclitaxel
Abraxane
Intervention: nab-Paclitaxel
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: Disease evaluation every 8 weeks up to 108 weeks
Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
Secondary Outcomes
- Overall Survival(Up to 108 weeks)
- Progression Free Survival(Up to 108 weeks)
- Disease control rate(Disease evaluation every 8 weeks up to 108 weeks)
- Number of Participants with Adverse Events(Every two weeks up to 24 weeks)