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Combination Chemotherapy and Interferon Alfa Followed by Surgery and/or Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004897
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with interferon alfa, surgery, and/or radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and interferon alfa followed by surgery and/or radiation therapy in treating patients who have stage I, stage II, or stage III esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
Biological: recombinant interferon alfa
Drug: cisplatin
Drug: fluorouracil
Drug: hydroxyurea
Drug: leucovorin calcium
Procedure: conventional surgery
Radiation: radiation therapy
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Radiation Therapy Surgery
Drug Information available for: Fluorouracil Leucovorin Cisplatin Citrovorum factor Interferon alfa-2a Interferon alfa-n1 Hydroxyurea Leucovorin Calcium Folinic acid calcium salt pentahydrate Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: PFL-Alpha Chemotherapy Followed by Surgery or FHX for Early Stage Esophageal Cancer - A Pilot Project

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1999
Detailed Description:

OBJECTIVES: I. Determine response rates, duration of response, and performance status in patients with stage I-III esophageal cancer after treatment with cisplatin, fluorouracil, interferon alfa, and leucovorin calcium. II. Determine toxicities of this regimen in these patients. III. Determine relapse and survival rates in this patient population treated with this regimen. IV. Determine response rates, duration of response, performance status, and relapse and survival rates for inoperable candidates in this patient population treated with this regimen followed by radiotherapy. V. Determine the toxicities of this regimen followed by radiotherapy in these patients. VI. Evaluate recurrence following this treatment regimen in this patient population. VII.

Compare roentgenographic and ultrasound responses to histopathologic responses with this regimen in this patient population. VIII. Evaluate the effects of this regimen and its relation to the ability to achieve negative surgical margins and evaluate the extent of multifocality, nodal disease, tumor size, and tumor grade. IX. Determine the incidence of perioperative complications following this regimen, including surgical as well as operative time, blood loss, perioperative transfusions, and length of hospital stay.

OUTLINE: Patients receive leucovorin calcium IV continuously on days 1-5.5, interferon alfa subcutaneously daily on days 1-6, cisplatin IV over 6 hours on day 1, and fluorouracil IV continuously on days 1-5. Treatment continues every 21 days for 3 courses in the absence of unacceptable toxicity.

Approximately 4 weeks after chemotherapy, esophagectomy is performed in patients without evidence of locally advanced unresectable esophageal cancer or distant metastases. Patients determined to have residual disease following esophagectomy will be considered for radiotherapy. Patients not undergoing esophagectomy receive chemoradiotherapy 21-28 days after completion of initial chemotherapy. Patients receive oral hydroxyurea every 12 hours on days 0-5 and fluorouracil IV continuously on days 1-5. Patients undergo radiotherapy to esophagus daily on days 1-5. Treatment continues every 14 days for 7 courses in the absence of unacceptable toxicity. Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 15-45 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I-III squamous cell carcinoma or adenocarcinoma of the esophagus and gastro-esophageal junction Unidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 270 days Hematopoietic: WBC greater than 3,000/mm3 Granulocyte count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, alkaline phosphatase, and SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine less than 2.0 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: No serious cardiovascular disease that would preclude study Other: No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer No serious chronic medical illness that would preclude study No acute or chronic unresolved infection Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004897

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Claudia Tellez, MD Hematology-Oncology Associates of Illinois
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067576, NU-94I1, NCI-G00-1679
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004897     History of Changes
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

Study placed in the following topic categories:
Antimetabolites
Interferon Type I, Recombinant
Immunologic Factors
Gastrointestinal Diseases
Hydroxyurea
Esophageal Neoplasms
Leucovorin
Squamous Cell Carcinoma
Cisplatin
Vitamins
Micronutrients
Interferon-alpha
Vitamin B Complex
Digestive System Neoplasms
Interferons
Trace Elements
Esophageal Cancer
Immunosuppressive Agents
Angiogenesis Inhibitors
Antiviral Agents
Carcinoma
Calcium, Dietary
Digestive System Diseases
Esophageal Disorder
Head and Neck Neoplasms
Fluorouracil
Epidermoid Carcinoma
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Interferon Type I, Recombinant
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Hydroxyurea
Esophageal Neoplasms
Hematologic Agents
Physiological Effects of Drugs
Leucovorin
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients
Growth Inhibitors
Angiogenesis Modulating Agents
Nucleic Acid Synthesis Inhibitors
Interferon-alpha
Vitamin B Complex
Antisickling Agents
Digestive System Neoplasms
Growth Substances
Interferons
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009