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Oxaliplatin, Irinotecan, and Capecitabine in Treating Patients With Metastatic or Inoperable Locally Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (Cancer)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00084617
  Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: capecitabine
Drug: irinotecan hydrochloride
Drug: oxaliplatin
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer
Drug Information available for: Irinotecan Irinotecan hydrochloride Capecitabine Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate any time after course 2 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of complete response any time after course 2 [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2004
Estimated Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine total response rate in patients with metastatic or inoperable locally advanced gastric or gastroesophageal junction adenocarcinoma treated with oxaliplatin, irinotecan, and capecitabine.
  • Determine the duration of total response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma

    • Metastatic or inoperable locally advanced disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.5 g/dL

Hepatic

  • AST and ALT ≤ 2 times upper limit of normal
  • Bilirubin ≤ 1.5 mg/dL

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No New York Heart Association class III or IV heart disease
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • Able to take oral medications
  • No prior allergic reaction to compounds of similar chemical or biological composition to oxaliplatin, irinotecan, or capecitabine
  • No known hypersensitivity to fluorouracil
  • No concurrent uncontrolled illness
  • No neuropathy grade 3 or greater
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent sargramostim (GM-CSF)

Chemotherapy

  • More than 4 weeks since prior chemotherapy and recovered
  • No more than 1 course of prior neoadjuvant chemotherapy and/or adjuvant chemotherapy with or without radiotherapy as primary treatment
  • No prior chemotherapy for metastatic or recurrent disease

Endocrine therapy

  • Not specified

Radiotherapy

  • See Chemotherapy
  • More than 4 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • At least 4 weeks since prior anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084617

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Joanna M. Brell, MD Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000365464, CASE-CWRU-010442, CASE-CWRU-1203, NCI-6449, CASE-1203, RPCI-I-38704
Study First Received: June 10, 2004
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00084617  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent gastric cancer
stage III gastric cancer
stage IV gastric cancer
adenocarcinoma of the esophagus
adenocarcinoma of the stomach
recurrent esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Study placed in the following topic categories:
Capecitabine
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Irinotecan
Stomach cancer
Camptothecin
Recurrence
Carcinoma
Oxaliplatin
Digestive System Diseases
Stomach Diseases
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Esophageal neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009