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

Gastric Cancer Clinical Trial

Official title:

A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00354224
• Other study ID #: MUSC-100829
• Secondary ID: MUSC-OX-33-064MU
• Status: Terminated
• Phase: Phase 2
• Start date: January 2005
• Est. completion date: August 2008

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• capecitabine

• oxaliplatin

Locations

Country	Name	City	State
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate as Determined by RECIST.	Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	Every 6 weeks through study completion for up to about 18 weeks
Secondary	Number of Adverse Events		From the start of study treatment through study completion for up to about 18 weeks
Secondary	Progression-free Survival		Every 6 weeks through study completion for up to about 18 weeks