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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00004897
• Other study ID #: NU 94I1
• Secondary ID: NU-94I1NCI-G00-1
• Status: Terminated
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: June 8, 2012
• Start date: October 1999
• Est. completion date: November 2007

Study information

• Verified date: June 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: November 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Biological:
• recombinant interferon alfa

Drug:
• cisplatin

• fluorouracil

• hydroxyurea

• leucovorin calcium

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,