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RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer
This study has been completed.
Sponsor:
Asan Medical Center
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01049620
First received: January 13, 2010
Last updated: January 11, 2015
Last verified: January 2015
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Advanced Gastric Cancer | Drug: RAD001, Capecitabine, Oxaliplatin | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Finding Study of RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer |
Resource links provided by NLM:
Further study details as provided by Yoon-Koo Kang, Asan Medical Center:
Primary Outcome Measures:
- To assess the maximum tolerated dose (MTD) [ Time Frame: 1year ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 1 year ]
- Biomarker study [ Time Frame: 1 year ]
- Response rate [ Time Frame: 2 years ]
| Enrollment: | 40 |
| Study Start Date: | February 2010 |
| Study Completion Date: | September 2013 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Xelox+RAD001 |
Drug: RAD001, Capecitabine, Oxaliplatin
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 |
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01049620
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049620
Locations
| Korea, Republic of | |
| Asan Medical Center, University of Ulsan College of Medicine | |
| Seoul, Korea, Republic of, 138-736 | |
Sponsors and Collaborators
Asan Medical Center
Investigators
| Principal Investigator: | Yoon-Koo Kang, MD, PhD | Asan Medical Center |
More Information
| Responsible Party: | Yoon-Koo Kang, Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT01049620 History of Changes |
| Other Study ID Numbers: |
AMC-ONCGI-0905 |
| Study First Received: | January 13, 2010 |
| Last Updated: | January 11, 2015 |
Keywords provided by Yoon-Koo Kang, Asan Medical Center:
|
XELOX RAD001 phase 1 |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Capecitabine Oxaliplatin Everolimus Sirolimus |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |
ClinicalTrials.gov processed this record on July 21, 2017