Clinical trial NCT02251951: Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach and Gastro-Esophageal Junction (GEJ) Cancer
Keywords: Cancer
Stomach
Gastro-Esophageal Junction
Salvage treatment
Nab-paclitaxel
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Disease evaluation every 8 weeks up to 108 weeks
Secondary outcomes:
measure: Disease control rate
timeFrame: Disease evaluation every 8 weeks up to 108 weeks
measure: Progression Free Survival
timeFrame: Up to 108 weeks
measure: Overall Survival
timeFrame: Up to 108 weeks
measure: Number of Participants with Adverse Events
timeFrame: Every two weeks up to 24 weeks
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
state: Crete
city: Athens
country: Greece
facility: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens Athens, Greece
city: Athens
country: Greece
facility: SOTIRIA Hospital, Medical Oncology Department
city: Chania
country: Greece
facility: "Ag. Georgios" General Hospital of Chania
city: Thessaloniki
country: Greece
facility: "PAPAGEORGIOY" General Hospital of Thessaloniki
Study officials:
affiliation: University Hospital of Herklion
name: John Souglakos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Heraklion
name: Vassilis Georgoulias, MD
role: PRINCIPAL_INVESTIGATOR
References: