Gastric Cancer RAD001 Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: RAD001
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Paclitaxel / Carboplatin / RAD001 as First Line Therapy for Advanced Adenocarcinoma of the Stomach

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Toxicity of combination Paclitaxel/carboplatin/RAD001 in advanced adenocarcinoma of the stomach and gastroesophageal junction [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: January 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514110

Contacts
Contact: Winnie Yeo, MD, FRCP 26322118 winnieyeo@cuhk.edu.hk
Contact: Jane Koh, RN 26321142 jane@clo.cuhk.edu.hk

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Winnie Yeo, MD, FRCP    2632 2118    winnieyeo@cuhk.edu.hk   
Contact: Jane Koh, RN    26321142    jane@clo.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Winnie Yeo, MD, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01514110     History of Changes
Other Study ID Numbers: GAT006
Study First Received: November 22, 2011
Last Updated: July 23, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Sirolimus
Everolimus
Carboplatin
Paclitaxel
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014