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

NCT01049620 | Completed Phase 1

• 1 other identifier: AMC0905
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Gastric Cancer

Keywords

XELOX; RAD001; phase 1

Outcome Measures

Primary Outcomes (1)

• To assess the maximum tolerated dose (MTD)

  1year

Secondary Outcomes (4)

• Progression-free survival

  2 years

• Overall survival

  1 year

• Biomarker study

  1 year

• Response rate

  2 years

Study Arms (1)

Xelox+RAD001

EXPERIMENTAL

Drug: RAD001, Capecitabine, Oxaliplatin

Interventions

RAD001, Capecitabine, Oxaliplatin DRUG

Dose level -1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 5mg po qd D1-21 Dose level 1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21 Dose level 2 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21 Dose level 3 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21 Dose level 3A : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21 Dose level 3B : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 10mg po qd D1-21 Dose level 4 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21 Dose level 5 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21

Xelox+RAD001

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

Everolimus; Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes

Study Officials

• Yoon-Koo Kang, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2013
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

KR (1)