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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004897
Recruitment Status : Terminated (Institutional Review Board requested termination - all patients deceased and no new accrual.)
First Posted : July 26, 2004
Last Update Posted : June 12, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

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 or disease Intervention/treatment Phase
Esophageal Cancer Biological: recombinant interferon alfa Drug: cisplatin Drug: fluorouracil Drug: hydroxyurea Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: PFL-Alpha Chemotherapy Followed by Surgery or FHX for Early Stage Esophageal Cancer - A Pilot Project
Study Start Date : October 1999
Actual Primary Completion Date : July 2007
Actual Study Completion Date : November 2007

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004897

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Study Chair: Claudia Tellez, MD Hematology-Oncology Associates of Illinois

Responsible Party: Northwestern University Identifier: NCT00004897     History of Changes
Other Study ID Numbers: NU 94I1
First Posted: July 26, 2004    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012

Keywords provided by Northwestern University:
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 Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antisickling Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors
Protective Agents