Expired Study
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Buffalo, New York 14263


Purpose:

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.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of oxaliplatin when given in combination with continuous-infusion fluorouracil and radiotherapy in patients with primary cancer of the thoracic esophagus or gastroesophageal junction. - Determine the pharmacokinetics of this regimen in this patient population. - Assess somatic p53 mutations in cancer of the esophagus and determine their relation to therapeutic response induced by this regimen. - Assess, in a preliminary manner, the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil. Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously on days 8-42. Patients also undergo radiotherapy once daily, 5 days a week, for 6 weeks beginning on day 8. Patients without evidence of distant disease or unresectable local regional invasion undergo esophageal resection between days 63-70 (within 3-4 weeks after completion of chemoradiotherapy). Patients then receive oxaliplatin as above on days 105, 119, and 133 and fluorouracil as above on days 105-147. Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 4 weeks. PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within approximately 3 years.


Criteria:

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


NCT ID:

NCT00004257


Primary Contact:

Study Chair
Lawrence P. Leichman, MD
Albany Medical College


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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