Status:
COMPLETED
RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
Lead Sponsor:
Asan Medical Center
Conditions:
Stomach Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00729482
Start Date
July 1 2008
End Date
March 1 2013
Last Update
January 7 2020
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpa, South Korea, 138-736