Esophageal Cancer Clinical Trial
Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
Summary
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.
Full Description
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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Buffalo New York, 14263, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.