Gastric Cancer
Conditions
Keywords
recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer
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.
Interventions
DRUGcapecitabine
DRUGoxaliplatin
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate as Determined by RECIST. | Every 6 weeks through study completion for up to about 18 weeks | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Adverse Events | From the start of study treatment through study completion for up to about 18 weeks |
| Progression-free Survival | Every 6 weeks through study completion for up to about 18 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxaliplatin + Capecitabine 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.
capecitabine
oxaliplatin | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Oxaliplatin + Capecitabine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 4 / 10 |
Outcome results
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.
Time frame: Every 6 weeks through study completion for up to about 18 weeks
Population: this data was not collected.
Secondary
Number of Adverse Events
Time frame: From the start of study treatment through study completion for up to about 18 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxaliplatin + Capecitabine | Number of Adverse Events | 4 Serious Adverse Events |
Secondary
Progression-free Survival
Time frame: Every 6 weeks through study completion for up to about 18 weeks
Population: data was not collected for this endpoint.