Status:
UNKNOWN
Oxaliplatin and S-1 or Oxaliplatin and Capecitabine in Treating Patients With Recurrent, Metastatic, or Unresectable Gastric Cancer
Lead Sponsor:
Yonsei University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, S-1, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividi...
Detailed Description
OBJECTIVES: Primary * To evaluate the time to progression in patients with recurrent or metastatic gastric cancer treated with oxaliplatin in combination with S-1 vs capecitabine. Secondary * To a...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the stomach
- Unresectable advanced disease or recurrent disease after resection
- At least one radiographically documented (CT scan or MRI) measurable or evaluable lesion in a previously non-irradiated area according to RECIST
- No clinical evidence of brain metastases or history of other CNS disease unless adequately treated
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Estimated life expectancy \> 3 months
- Hemoglobin ≥ 9 g/dL
- White blood cell ≥ 4,000/µL
- ANC ≥ 2,000/µL
- Platelets ≥ 100,000/µL
- Bilirubin ≤ 1.25 times upper limit of normal (ULN) (≤ 2.0 times ULN if hepatic metastasis present)
- Serum creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 60 mL/min
- AST/ALT ≤ 3.0 times ULN (≤ 5.0 times ULN if hepatic metastasis present)
- Alkaline phosphatase ≤ 3.0 times ULN (≤ 5.0 times ULN if bone metastasis present)
- Must have an intact gastrointestinal tract
- Able to take oral medications
- No medically uncontrolled severe infections or complications
- No prior malignancy other than gastric cancer in the last 5 years except for basal cell cancer of the skin or preinvasive cancer of the cervix
- Not pregnant or nursing
- No neuropathy ≥ grade 2
- No clinically relevant heart disease
- No evidence of past medical history or psychosocial dysfunction that contraindicates the use of an investigational drug or puts the patient at risk
- No dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- No uncontrolled hepatitis B or C, chronic liver disease, or diabetes mellitus
- No other evidence of inappropriate suspicious condition
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for advanced or recurrent disease
- Prior adjuvant chemotherapy allowed if finished \> 6 months before start of study treatment
- No prior therapeutic radiotherapy
- Prior palliative radiotherapy allowed if it was not done for primary, evaluable, or intraabdominal lesions
- No prior capecitabine or oxaliplatin
- No other concurrent chemotherapy or radiotherapy (except localized radiotherapy for pain relief)
- No concurrent chemically related analogues, such as warfarin, phenytoin, or allopurinol
- No concurrent steroid therapy except as follows:
- Prophylactic use for hypersensitivity control or antiemetic purpose allowed
- Chronic low dose of steroid (less than methylprednisolone 20 mg or equivalent dose) allowed
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00985556
Start Date
January 1 2009
Last Update
October 20 2011
Active Locations (1)
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1
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea, 120-752