Stomach and Gastro-Esophageal Junction (GEJ) Cancer Clinical Trial
Official title:
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
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 | Athens | |
| Greece | "Ag. Georgios" General Hospital of Chania | Chania | |
| Greece | University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece | Heraklion | Crete |
| Greece | "PAPAGEORGIOY" General Hospital of Thessaloniki | Thessaloniki |
| Lead Sponsor | Collaborator |
|---|---|
| Hellenic Oncology Research Group |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Number of Participants with Adverse Events | Every two weeks up to 24 weeks | Yes |