Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer

NCT00446290 | Completed Phase 1 Results

• 1 other identifier: AMC0609
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

To determine maximal tolerated dose of DXO regimen

Outcome Measures

Primary Outcomes (1)

• Number of Participants With DLTs

  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

Study Arms (1)

Docetaxel, Capecitabine and Oxaliplatin

EXPERIMENTAL

Drug: Docetaxel, Capecitabine and Oxaliplatin

Interventions

Docetaxel, Capecitabine and Oxaliplatin DRUG

Docetaxel, Capecitabine and Oxaliplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes

Results Point of Contact

• Title: Dr. Yoon-Koo Kang
• Organization: Asan Medical Center

ykkang@amc.seoul.kr

+82-2-3010-3210

Study Officials

• Yoon-Koo Kang, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 12, 2007
• Study Start: March 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: January 18, 2020
• Results First Posted: July 28, 2015

Record last verified: 2020-01

Locations

KR (1)