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Esophageal Cancer: A Phase II Study of Paclitaxel, Carboplatin and 5-Fluorouracil With Simultaneous Radiotherapy Followed by Surgical Resection

Phase 2
Open (Enrolling)
Esophageal Cancer

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Trial Information

Esophageal Cancer: A Phase II Study of Paclitaxel, Carboplatin and 5-Fluorouracil With Simultaneous Radiotherapy Followed by Surgical Resection

OBJECTIVES: I. Determine the total response rate in patients with stage I, II, or III
esophageal cancer treated with paclitaxel, carboplatin, and fluorouracil with concurrent
radiotherapy followed by surgical resection. II. Determine the overall survival of these
patients treated with this regimen. II. Determine the toxicity of this regimen in this
patient population.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30
minutes on days 1 and 22, and fluorouracil IV continuously on days 1-42. Patients undergo
radiotherapy concurrently with chemotherapy daily 5 days a week for 5 weeks. Patients then
undergo surgical resection within 3-5 weeks following completion of therapy. Patients are
followed every 3 months for 6 months, every 6 months for 1 year, and then annually

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or
adenocarcinoma of the upper, middle, or lower third esophagus Stage I, II, or III disease
Measurable disease No distant metastases Negative liver biopsy Negative bone scan unless
due to benign disease No tracheobronchial involvement No vocal cord paralysis No phrenic
nerve involvement No celiac axis lymph node involvement unless due to primary cancer at
gastroesophageal junction No evidence of disseminated cancer

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5
mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase
no greater than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine
clearance at least 60 mL/min Cardiovascular: No uncontrolled or severe cardiovascular
disease No congestive heart failure No myocardial infarction within the past 6 months No
severe or uncontrolled hypertension (systolic greater than 150 mmHg and diastolic greater
than 100 mmHg) Pulmonary: FEV1/FVC at least 75% predicted Arterial blood saturation at
least 92% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No other malignancy except curatively treated nonmelanoma skin
cancer or carcinoma in situ of the cervix No other serious medical illness that would
limit survival to fewer than 2 years No active uncontrolled bacterial, viral, or fungal
infection No active uncontrolled duodenal ulcer No psychiatric disorder that would
preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest radiotherapy
Surgery: No prior surgical resection of tumor Other: No prior therapy for esophageal

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David J. Perry, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington Hospital Center


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

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



Harbor Hospital Center Baltimore, Maryland  21225
Franklin Square Hospital Center Baltimore, Maryland  21237
Washington Cancer Institute Washington, District of Columbia  20010
Washington Hospital Center Washington, District of Columbia  20010
Union Memorial Hospital Baltimore, Maryland  21218
Good Samaritan Hospital of Maryland Baltimore, Maryland  21239