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

Medical University of South Carolina (MUSC)

Status and phase: Terminated; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: oxaliplatin; Drug: capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00354224

MUSC-100829

CDR0000484638 (Registry Identifier)

MUSC-OX-33-064

MUSC-HR-11497

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Oxaliplatin + Capecitabine

Experimental group

Description:

Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day.

Treatment:

Drug: oxaliplatin

Drug: capecitabine