Gastric Cancer RAD001 Study

This study is currently recruiting participants.
Verified January 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01514110
First received: November 22, 2011
Last updated: January 14, 2014
Last verified: January 2014

November 22, 2011
January 14, 2014
January 2008
December 2015   (final data collection date for primary outcome measure)
to determine the Maximum tolerated dose and dose limiting toxicity of RAD001 in combination with paclitaxel and carboplatin [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01514110 on ClinicalTrials.gov Archive Site
Toxicity of combination Paclitaxel/carboplatin/RAD001 in advanced adenocarcinoma of the stomach and gastroesophageal junction [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Gastric Cancer RAD001 Study
Phase I/II Study of Paclitaxel / Carboplatin / RAD001 as First Line Therapy for Advanced Adenocarcinoma of the Stomach

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
Drug: RAD001
Pharmacology of RAD001 as a combination partner for conventional agents.
Other Name: RAD001 with Paclitaxel 175 mg/m2 and carboplatin (AUC=5) on Day 1, every 3 weeks until PD
Experimental: RAD001
Intervention: Drug: RAD001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
53
December 2015
December 2015   (final data collection date for primary outcome measure)

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 RAD001.

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 RAD001.
  • 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
  • Pre-existing neuropathy of >= grade 2
  • Patients with a history of second malignancies are eligible they have been disease free for at least 5 years and are deemed by the investigator to be at low risk of recurrence. Par8entswith the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin
  • Pregnancy or lactation.
Both
18 Years and older
No
Contact: Winnie Yeo, MD, FRCP 26322118 winnieyeo@cuhk.edu.hk
Contact: Jane Koh, RN 26321142 jane@clo.cuhk.edu.hk
Hong Kong
 
NCT01514110
GAT006
No
CCTU, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Winnie Yeo, MD, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong
Chinese University of Hong Kong
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP