Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer

NCT ID: NCT00446290

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-10-31

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.

Conditions

Stomach Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel, Capecitabine and Oxaliplatin

Group Type: EXPERIMENTAL

Docetaxel, Capecitabine and Oxaliplatin

Intervention Type: DRUG

Interventions

Docetaxel, Capecitabine and Oxaliplatin

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yoon-Koo Kang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoon-Koo Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMC0609

Identifier Type: -

Identifier Source: org_study_id