RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer: RAD001+XELOX

Asan Medical Center

Status and phase

Completed

Phase 1

Conditions

Advanced Gastric Cancer

Treatments

Drug: RAD001, Capecitabine, Oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01049620

AMC0905

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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