Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: fluorouracil Drug: oxaliplatin Procedure: conventional surgery Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer |
| Study Start Date: | January 2000 |
| Study Completion Date: | January 2004 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Study Chair: | Lawrence P. Leichman, MD | Albany Medical College |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00004257 History of Changes |
| Other Study ID Numbers: | CDR0000067504, ALB-RPCI-DS-99-08, RPCI-DS-99-08, NCI-T99-0061 |
| Study First Received: | January 28, 2000 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Fluorouracil |
Oxaliplatin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013