Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006472
• Other study ID #: CDR0000068295
• Secondary ID: WHC-99692NCI-V00
• Status: Terminated
• Phase: Phase 2
• Start date: January 2000
• Est. completion date: September 10, 2002

Study information

• Verified date: February 2002
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy given before surgery in treating patients who have stage I, stage II, or stage III esophageal cancer.

Description:

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 thereafter.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 10, 2002
• Est. primary completion date: November 15, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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 cancer

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• carboplatin
Carboplatin AUC 6 days 1 and 22
• fluorouracil
5FU 225mg/m2 continuous infusion on days 1-42 during radiation
• paclitaxel
taxol

Procedure:
• conventional surgery

Radiation:
• radiation therapy
The initial fields should be treated AP:PA when possible to a dose of 4500 cGy in 180 cGy fractions

Locations

Country	Name	City	State
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Good Samaritan Hospital of Maryland	Baltimore	Maryland
United States	Harbor Hospital Center	Baltimore	Maryland
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Washington Cancer Institute	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States,