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


Phase 2
N/A
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Claudia Tellez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hematology-Oncology Associates of Illinois

Authority:

United States: Federal Government

Study ID:

NU 94I1

NCT ID:

NCT00004897

Start Date:

October 1999

Completion Date:

November 2007

Related Keywords:

  • Esophageal Cancer
  • stage I esophageal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611