Back to resultsRAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer: RAD001+XELOX
Primary Purpose
Advanced Gastric Cancer
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RAD001, Capecitabine, Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring XELOX, RAD001, phase 1
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically documented unresectable or metastatic adenocarcinoma of stomach or gastroesophageal junction
- No history of chemotherapy or radiation
- Age 18 to 70 years old
- Estimated life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow function (white blood cell counts >3,000/uL, absolute neutrophil count>1,500/uL, Platelets>100,000/uL, Hgb>8 g/dL)
- Adequate kidney function (creatinine<1.5 mg/dL)
- Adequate liver function (bilirubin<1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <3 times the upper normal limit (5 times for patients with liver metastasis))
- Signed written informed consent
Exclusion Criteria:
- Past or concurrent history of neoplasm other than gastric adenocarcinoma except for curatively treated basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
- Presence of central nervous system metastasis
- Bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy (NCI CTC AE version 3.0 > Grade I)
- History of significant neurologic or psychiatric disorders
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
- Patients with known history of ischemic heart disease and/or with myocardial infarction
- Known allergy to study drugs
- Administration of drugs showing interaction with RAD001
Sites / Locations
- Asan Medical Center, University of Ulsan College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xelox+RAD001
Arm Description
Outcomes
Primary Outcome Measures
To assess the maximum tolerated dose (MTD)
Secondary Outcome Measures
Progression-free survival
Overall survival
Biomarker study
Response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01049620
Brief Title
RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer: RAD001+XELOX
Official Title
A Phase I Dose Finding Study of RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in combination with conventional chemotherapy. In this study, XELOX was selected as a conventional combination chemotherapy because it was proven very active and safe in gastric cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer patients yet. So, the optimal dose will be first determined in this phase I study
Detailed Description
For the first cohort of this phase I study, each drug of capecitabine, oxaliplatin, and RAD001 will be started at one or two dose below the ordinary full dose of each drug as a single agent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer
Keywords
XELOX, RAD001, phase 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xelox+RAD001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RAD001, Capecitabine, Oxaliplatin
Intervention Description
Dose level -1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 5mg po qd D1-21
Dose level 1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21
Dose level 2 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21
Dose level 3 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21
Dose level 3A : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21
Dose level 3B : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 10mg po qd D1-21
Dose level 4 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21
Dose level 5 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21
Primary Outcome Measure Information:
Title
To assess the maximum tolerated dose (MTD)
Time Frame
1year
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
2 years
Title
Overall survival
Time Frame
1 year
Title
Biomarker study
Time Frame
1 year
Title
Response rate
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented unresectable or metastatic adenocarcinoma of stomach or gastroesophageal junction
No history of chemotherapy or radiation
Age 18 to 70 years old
Estimated life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate bone marrow function (white blood cell counts >3,000/uL, absolute neutrophil count>1,500/uL, Platelets>100,000/uL, Hgb>8 g/dL)
Adequate kidney function (creatinine<1.5 mg/dL)
Adequate liver function (bilirubin<1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <3 times the upper normal limit (5 times for patients with liver metastasis))
Signed written informed consent
Exclusion Criteria:
Past or concurrent history of neoplasm other than gastric adenocarcinoma except for curatively treated basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
Presence of central nervous system metastasis
Bowel obstruction
Evidence of serious gastrointestinal bleeding
Peripheral neuropathy (NCI CTC AE version 3.0 > Grade I)
History of significant neurologic or psychiatric disorders
Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Other serious illness or medical conditions
Patients with known history of ischemic heart disease and/or with myocardial infarction
Known allergy to study drugs
Administration of drugs showing interaction with RAD001
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer: RAD001+XELOX
We'll reach out to this number within 24 hrs