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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00446290
First received: March 9, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Stomach Cancer
Drug: Docetaxel, Capecitabine and Oxaliplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Docetaxel, Capecitabine and Oxaliplatin (DXO) in Patients With Advanced Stomach Cancer

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • maximal tolerated dose [ Time Frame: 2years ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00446290     History of Changes
Other Study ID Numbers: AMC0601
Study First Received: March 9, 2007
Last Updated: August 1, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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
Oxaliplatin
Docetaxel
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 31, 2014