Clinical trial · Interventional
Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
NCT00040859CI-TRIAL-00025063completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- oxaliplatin + capecitabine
- description
- Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR. Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy). Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
- interventionNames
- Drug: capecitabine
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- Objective tumor response rate
- timeFrame
- Up to 3 years
Secondary outcomes (3)
- measure
- Time to progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists * Unresectable disease * Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach * Measurable disease * No known CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * AST no greater than 3 times ULN * Alkaline phosphatase no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Able to swallow capecitabine * No unresolved gastrointestinal bleeding * No uncontrolled infection * No chronic debilitating disease * No peripheral neuropathy grade 2 or greater * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy or biological therapy for recurrent or metastatic disease * No concurrent biologic agents Chemotherapy: * No prior chemotherapy for recurrent or metastatic disease * Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Chemotherapy * No prior radiotherapy for recurrent or metastatic disease * No prior radiotherapy to more than 25% of the bone marrow * Prior adjuvant or neoadjuvant radiotherapy allowed * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * More than 4 weeks since prior abdominal exploration with surgical resection * More than 3 weeks since prior abdominal exploration without surgical resection Other: * No concurrent oral cryotherapy during oxaliplatin administration
References
Publications (2)
- BACKGROUNDJatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535. PMID 20126980
- RESULTJatoi A, Murphy BR, Foster NR, Nikcevich DA, Alberts SR, Knost JA, Fitch TR, Rowland KM Jr; North Central Cancer Treatment Group. Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group. Ann Oncol. 2006 Jan;17(1):29-34. doi: 10.1093/annonc/mdj063. Epub 2005 Nov 22. PMID 16303863