Phase I/II Study of Paclitaxel / Carboplatin / RAD001 as First Line Therapy for Advanced Adenocarcinoma of the Stomach

Chinese University of Hong Kong1 site in 1 country35 target enrollmentJanuary 23, 2008

ConditionsGastric Cancer

InterventionsRAD001

DrugsRAD001

Overview

Phase: Phase 1
Intervention: RAD001
Conditions: Gastric Cancer
Sponsor: Chinese University of Hong Kong
Enrollment: 35
Locations: 1
Primary Endpoint: to determine the Maximum tolerated dose and dose limiting toxicity of RAD001 in combination with paclitaxel and carboplatin
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of RAD001, as well as to assess tumor response and overall survival.

Registry

clinicaltrials.gov

Start Date

January 23, 2008

End Date

March 6, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chinese University of Hong Kong

Responsible Party

Principal Investigator

CCTU

Comprehensive Clinical Trial Unit

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically proven adenocarcinoma of the stomach. Patients who have adenocarcinoma of the gastroesophageal junction will be eligible if the majority of the tumor bulk is below the junction.
•Metastatic or Loco-regionally advanced disease
•Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT /MRI scan. See section 11.2 for the evaluation of measurable disease.
•Age \>= 18 years.
•Life expectancy of greater than 12 weeks.
•ECOG performance status \<= 2 (Karnofsky \>= 60%).

Exclusion Criteria

•Patients who have received more than one line of palliative chemotherapy are allowed, provided that (i) the prior chemotherapy does not contain taxane, cisplatin or carboplatin; (ii) 4 weeks have elapsed prior to the start of the current study treatment, and that (iii) they have recovered from adverse events due to previous treatment \[except alopecia\].
•Patients who have had radiotherapy or major surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to treatment administered more than 4 weeks earlier.
•Patients who are on CYP3A4 modifiers are excluded from the study
•Patients with known brain metastases.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD
•Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
•Patients with severe concurrent medical illness such as severe impairment of lung function should be excluded from studies of RAD
•Uncontrolled intercurrent such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
•Poorly controlled diabetes mellitus
•High LDL cholesterol or triglyceride level