Chicago, Illinois 60611

  • Esophageal Cancer


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.

Study summary:

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.


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

Study is Available At:

Original ID:

NU 94I1



Secondary ID:


Study Acronym:

Brief Title:

Combination Chemotherapy and Interferon Alfa Followed by Surgery and/or Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Es

Official Title:

PFL-Alpha Chemotherapy Followed by Surgery or FHX for Early Stage Esophageal Cancer - A Pilot Project

Overall Status:


Study Phase:

Phase 2



Minimum Age:


Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Northwestern University

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Institutional Review Board requested termina

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Claudia Tellez, MD
Study Chair
Hematology-Oncology Associates of Illinois

Study Dates

Start Date:October 1999
Completion Date:November 2007
Completion Type:Actual
Primary Completion Date:July 2007
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 8, 2012
First Received Date:March 7, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Radiation
Name:radiation therapy
Intervention Type:Procedure
Name:conventional surgery
Intervention Type:Drug
Name:leucovorin calcium
Intervention Type:Drug
Intervention Type:Drug
Intervention Type:Drug
Intervention Type:Biological
Name:recombinant interferon alfa

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Northwestern University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: July 27, 2021

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