Clinical trial NCT00354224: Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer
Official title: A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: recurrent gastric cancer
stage III gastric cancer
stage IV gastric cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2006-07-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Response Rate as Determined by RECIST.
timeFrame: Every 6 weeks through study completion for up to about 18 weeks
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: From the start of study treatment through study completion for up to about 18 weeks
measure: Progression-free Survival
timeFrame: Every 6 weeks through study completion for up to about 18 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Uzair B. Chaudhary, MD
role: STUDY_CHAIR
affiliation: Medical University of South Carolina, Hollings Cancer Center
name: Gustavo Leone
role: STUDY_CHAIR
References: