Clinical trial · Interventional
Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer
NCT00004257CI-TRIAL-00009829completedPhase 1ClinicalTrials.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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil plus radiation therapy in treating patients who have primary esophageal or stomach cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm from incisors) or gastroesophageal (GE) junction * Stage I-III * Bronchoscopy with biopsy and cytology required if primary esophageal cancer is less than 26 cm from incisors * No disease outside esophagus and peri-esophageal soft tissue * GE junction tumors must be confined to no greater than 2 cm into the gastric cardia * Supraclavicular lymph nodes at station 1 must be less than 1.5 cm or nonpalpable by physical examination * Nodes 1.5 cm or greater or palpable by physical examination must be confirmed to be nonmalignant by biopsy * Subdiaphragmatic lymph nodes at stations 15-20 must be no greater than 1.5 cm * No recurrent disease * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No grade 2 peripheral neuropathy * No history of allergy to platinum compounds * No history of allergy to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy * No other concurrent uncontrolled illness * No ongoing or active infection * No other malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: * No colony-stimulating factor therapy during first study course Chemotherapy: * No prior chemotherapy for esophageal cancer * At least 4 weeks since other prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for esophageal cancer * At least 4 weeks since other prior radiotherapy Surgery: * No prior resection or attempted resection of esophageal cancer Other: * No other concurrent investigational drugs * No other concurrent commercial agents or therapies for esophageal cancer * No concurrent highly active antiretroviral agents (HAART) for HIV-positive patients
References
Publications (3)
- BACKGROUNDSmith PF, Booker B, Pendyala L, et al.: Pharmacokinetic modeling of oxaliplatin with and without 5-FU and radiation. [Abstract] Proc Am Assoc Cancer Res 42: A-2913, 542, 2001.
- RESULTKhushalani N, Nava H, Leichman CG, et al.: A phase I study of oxaliplatin in combination with continous infusion 5-fluorouracil and radiation in esophagus cancer. [Abstract] Proc Am Assoc Cancer Res 42: A-3751, 697, 2001.
- RESULTPendyala L, Leichman CG, Clark K, et al.: Oxaliplatin, 5-fluorouracil, and radiation in cancer of the esophagus: a pharmacokinetic (PK)/molecular correlates study. [Abstract] Proc Am Assoc Cancer Res 42: A-3347, 623, 2001.