RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
Condition: Stomach Neoplasm
MeSH terms: Stomach Neoplasms
Intervention: RAD001
Intervention description: RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: RAD001 (everolimus); second-line treatment; advanced gastric cancer

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%.
    

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