MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer

Inclusion Criteria:

1. At least 18 years of age
2. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (GEJ)
3. Measurable disease based on computed tomography
4. Eastern Cooperative Oncology Group performance status 0 or 1
5. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum agent
6. Disease progression after the start of the prior regimen based on computed tomography (or magnetic resonance imaging in the event of allergy to contrast medium)
7. Adequate bone marrow, hepatic, and renal function,
8. At least 4 weeks and recovery from effects of prior major surgery or radiation therapy
9. If previously administered as treatment for gastric cancer, prior to study entry a washout period equivalent to at least 5 half-lives for antibodies and of at least 28 days for chemotherapy (Concurrent use of bisphosphonates is permitted.)
10. Ability to swallow an oral solid-dosage form of medication, including when a feeding tube is present
11. A negative serum pregnancy test within 7 days prior to accrual in women of childbearing potential
12. Agreement to use an effective form of contraception
13. Signed written informed consent.
14. Ability to comprehend and to comply with the requirements of the study.

Exclusion Criteria:

1. Squamous cell gastric carcinoma
2. Bone-only metastatic disease
3. History or presence of brain metastasis or leptomeningeal disease
4. Operable gastric or GEJ cancer
5. Herceptin 2 (HER2) -positive disease if the subject has not previously been treated with an anti-HER2 agent
6. Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the subject's usual number of bowel movements on at least 3 days within the 14 days prior to study entry
7. Nausea or vomiting for at least 3 consecutive days within the 14 days prior to study entry despite the administration of standard antiemetic therapy
8. Known malabsorptive disorder
9. Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)
10. Human immunodeficiency virus infection based on history of positive serology
11. Significant medical disease other than gastric cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study
12. Presence of neuropathy \> Grade 1
13. Prior treatment including docetaxel
14. Prior radiation therapy to more than 25% of the bone marrow
15. Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy
16. History of severe or unexpected reaction to fluoropyrimidine therapy
17. History of hypersensitivity to fluoropyrimidine agents or any of their ingredients.
18. Known dihydropyrimidine dehydrogenase deficiency
19. Pregnancy or lactation