- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00446290
Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer
January 6, 2020 updated by: Yoon-Koo Kang, Asan Medical Center
A Phase I Study of Docetaxel, Capecitabine and Oxaliplatin (DXO) in Patients With Advanced Stomach Cancer
Considering synergism between docetaxel (D), capecitabine (X), and oxaliplatin (O) and favourable toxicity profile of oxaliplatin over cisplatin, it is to be expected that combination of docetaxel, capecitabine, and oxaliplatin (DXO) will be more effective than other regimens and feasible in advanced gastric cancer.
DXO regimen can be also easily administered on out-patient setting.
However, so far, DXO combination has not been tried in advanced gastric cancer.
The investigators will determine maximum tolerated dose of DXO regimen in this phase I study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 138-736
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma
- Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel, capecitabine, or oxaliplatin as adjuvant chemotherapy should be excluded.)
- Age 18 to 70 years old
- Eastern Cooperative Oncology Group performance status 0~2
- Adequate bone marrow function: white blood cell counts >4,000/µL, absolute neutrophil count >2,000/µL, and platelets>100,000/µL
- Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance 60ml/min
- Adequate hepatic function: bilirubin < 1.5 x UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels < 2.5 x UNL, and alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease)
- Given written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
Exclusion Criteria:
- Contraindication to any drug contained in the chemotherapy regimen
- Other tumor type than adenocarcinoma
- Presence or history of central nervous system (CNS) metastasis
- Gastric outlet or bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy > grade 1
- History of significant neurologic or psychiatric disorders
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential
- Sexually active males and females (of childbearing potential) unwilling to practice conception during the study
- Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in electrocardiogram) or myocardial infarction within the last 6 months
- Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
- Serious metabolic disease such as severe non-compensated diabetes mellitus
- Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- Positive serology for the human immunodeficiency virus (HIV)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docetaxel, Capecitabine and Oxaliplatin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With DLTs
Time Frame: 2 years
|
Dose limiting toxicity (DLTs) was determined during the Wrst two cycles of treat- ment.
The definitions of DLTs were as follows: (1) grade 4 neutropenia lasting for more than 5 days, or grade 3/4 neu- tropenia with fever; (2) grade 4 thrombocytopenia; (3) any other grade 3 non-hematological toxicity (excluding alope- cia); or (4) treatment delay of more than 2 weeks following the time of planned treatment.
Maximal tolerated dose was defined as that the DLTs were observed in two or more patients from a cohort of two to six patients
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
March 9, 2007
First Submitted That Met QC Criteria
March 9, 2007
First Posted (Estimate)
March 12, 2007
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 6, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- AMC0609
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stomach Cancer
-
Jeeyun LeeRecruitingStomach Cancer, AdenocarcinomaKorea, Republic of
-
Chinese University of Hong KongUnknown
-
Chinese University of Hong KongUnknown
-
Ohio State University Comprehensive Cancer CenterPharmacia and UpjohnCompletedStomach Cancer | Esophageal Cancer | Cancer of Stomach | Esophagus CancerUnited States
-
BayerCompletedPrevention of Oesophagus Cancer and Stomach CancerUnited Kingdom
-
Xijing Hospital of Digestive DiseasesCompletedStomach Cancer | Esophageal Cancer | Esophageal Dysplasia | Stomach DysplasiaChina
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Genentech, Inc.; SCRI Development Innovations... and other collaboratorsCompletedStomach Cancer | Gastric Cancer | Esophageal CancerUnited States
-
Chinese University of Hong KongRecruiting
-
MacroGenicsMerck Sharp & Dohme LLCCompletedStomach Cancer | Gastric Cancer | Esophageal CancerKorea, Republic of, United States, Taiwan, Singapore, Canada
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Genentech, Inc.; Brigham and Women's HospitalCompletedStomach Cancer | Esophageal CancerUnited States
Clinical Trials on Docetaxel, Capecitabine and Oxaliplatin
-
SanofiCompletedStomach NeoplasmsFrance, Russian Federation, Portugal, Spain, United States, Turkey, Belgium, Hungary, Italy, United Kingdom, Germany, Switzerland
-
Asan Medical CenterSeoul National University Bundang Hospital; Severance Hospital; Hallym University... and other collaboratorsRecruitingGastric Cancer, Adjuvant Chemotherapy, XOKorea, Republic of
-
LiNingNot yet recruitingStomach NeoplasmsChina
-
National Health Research Institutes, TaiwanMackay Memorial Hospital; Taipei Veterans General Hospital, Taiwan; National... and other collaboratorsTerminatedGastric AdenocarcinomaTaiwan
-
Spanish Cooperative Group for the Treatment of...Sanofi; Hoffmann-La RocheCompleted
-
Qun ZhaoJiangsu HengRui Medicine Co., Ltd.Completed
-
Martin-Luther-Universität Halle-WittenbergCompletedStomach NeoplasmsGermany
-
Taipei Veterans General Hospital, TaiwanUnknown
-
Samsung Medical CenterNational Cancer Center, Korea; Asan Medical Center; Chonnam National University... and other collaboratorsCompletedColorectal CancerKorea, Republic of
-
Ruijin HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting