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Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer (DXO)

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ClinicalTrials.gov Identifier: NCT00446290
Recruitment Status : Completed
First Posted : March 12, 2007
Results First Posted : July 28, 2015
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stomach Cancer Drug: Docetaxel, Capecitabine and Oxaliplatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Docetaxel, Capecitabine and Oxaliplatin (DXO) in Patients With Advanced Stomach Cancer
Study Start Date : March 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Docetaxel, Capecitabine and Oxaliplatin Drug: Docetaxel, Capecitabine and Oxaliplatin



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446290


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Yoon-Koo Kang, MD, PhD Asan Medical Center

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00446290     History of Changes
Other Study ID Numbers: AMC-ONCGI-0609
First Posted: March 12, 2007    Key Record Dates
Results First Posted: July 28, 2015
Last Update Posted: August 21, 2017
Last Verified: July 2017

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
To determine maximal tolerated dose of DXO regimen

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Oxaliplatin
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites