Back to resultsRAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
Primary Purpose
Stomach Neoplasm
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RAD001
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasm focused on measuring RAD001 (everolimus), second-line treatment, advanced gastric cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction
- Patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination)
- Patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-FU, capecitabine, doxifluridine, S1, or UFT) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy
- Age 18 to 75 years old
- Estimated life expectancy of more than 3 months
- ECOG performance status of 2 or lower
- Adequate bone marrow function
- Adequate kidney function
- Adequate liver function
- No prior radiation therapy to more than 25 percent of BM
- Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
- Women of childbearing potential must have a negative pregnancy test on admission
- The patient must be able to understand the study and has given written informed consent to participate in the study
Exclusion Criteria:
- Other tumor types than adenocarcinoma
- Central nervous system metastases or prior radiation for CNS metastasis
- Gastric outlet obstruction or intestinal obstruction
- Evidence of active gastrointestinal bleeding
- Bony metastasis as the sole evaluable disease
- Past or concurrent history of neoplasm other than stomach cancer
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Thyroid disease
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Treatment Arm (RAD001)
Outcomes
Primary Outcome Measures
Progression-free Survival Rate at 4-month (16 Weeks)
progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion
Secondary Outcome Measures
Response Rate
Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D). A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer. A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions. Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions. Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion.
Overall Survival
Number of Participants With Adverse Events
(according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00729482
Brief Title
RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
Official Title
A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 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
This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free survival rate (primary end-point) and response rate, toxicity, and overall survival (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer.
Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer who failed previous first-line standard treatment with fluoropyrimidine and platinum-based chemotherapy.
Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted according to the observed clinical toxicities. Treatment will be continued until disease progression or patient's intolerability to the study drug.
Total of 54 patients will be enrolled to decide whether the proportion of patients who are free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate, 10%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
Keywords
RAD001 (everolimus), second-line treatment, advanced gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Treatment Arm (RAD001)
Intervention Type
Drug
Intervention Name(s)
RAD001
Other Intervention Name(s)
everolimus
Intervention Description
RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
Primary Outcome Measure Information:
Title
Progression-free Survival Rate at 4-month (16 Weeks)
Description
progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion
Time Frame
4 months (16 weeks)
Secondary Outcome Measure Information:
Title
Response Rate
Description
Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D). A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer. A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions. Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions. Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion.
Time Frame
2years
Title
Overall Survival
Time Frame
1 year
Title
Number of Participants With Adverse Events
Description
(according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction
Patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination)
Patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-FU, capecitabine, doxifluridine, S1, or UFT) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy
Age 18 to 75 years old
Estimated life expectancy of more than 3 months
ECOG performance status of 2 or lower
Adequate bone marrow function
Adequate kidney function
Adequate liver function
No prior radiation therapy to more than 25 percent of BM
Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
Women of childbearing potential must have a negative pregnancy test on admission
The patient must be able to understand the study and has given written informed consent to participate in the study
Exclusion Criteria:
Other tumor types than adenocarcinoma
Central nervous system metastases or prior radiation for CNS metastasis
Gastric outlet obstruction or intestinal obstruction
Evidence of active gastrointestinal bleeding
Bony metastasis as the sole evaluable disease
Past or concurrent history of neoplasm other than stomach cancer
Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Thyroid disease
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
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