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Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00354224
First received: July 19, 2006
Last updated: January 23, 2009
Last verified: January 2008
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.


Condition Intervention Phase
Gastric Cancer
 Drug: capecitabine
Drug: oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerance [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Median and progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: January 2005
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response proportion in patients with locally advanced, unresectable, or metastatic gastric cancer treated with capecitabine and oxaliplatin.

Secondary

  • Determine the tolerability and toxicity of this regimen in these patients.
  • Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

  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 cancer

    • Locally advanced, unresectable, or metastatic disease
  • Measurable disease, defined as at least 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin normal
  • AST/ALT ≤ 2.5 times upper limit of normal
  • Creatinine ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study and for 6 months after completion of study treatment
  • Able to swallow
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fluoropyrimidines or platinum chemotherapy agents

  • No uncontrolled intercurrent illness including, but not limited to the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situations that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 6 months since prior radiotherapy with capecitabine as a radioenhancer
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent chemotherapy
  • No concurrent palliative radiotherapy

  • No concurrent hormonal therapy except for the following:

    • Steroids for adrenal failure
    • Hormones for nondisease related conditions (e.g., insulin for diabetes)
    • Intermittent use of dexamethasone as an antiemetic
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354224

Locations
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Study Chair: Uzair B. Chaudhary, MD Medical University of South Carolina
  More Information

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

No publications provided

ClinicalTrials.gov Identifier: NCT00354224     History of Changes
Other Study ID Numbers: CDR0000484638, MUSC-OX-33-064, MUSC-HR-11497, MUSC-100829
Study First Received: July 19, 2006
Last Updated: January 23, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent gastric cancer
stage III gastric cancer
stage IV gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013