Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Sponsor

Fox Chase Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00021320

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

107

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

Determine the median and two-year disease-free and overall survival of patients with resectable esophageal cancer treated with neoadjuvant paclitaxel, cisplatin, and fluorouracil with concurrent radiotherapy.
Determine the complete and partial responses in patients treated with this regimen.
Assess the toxicity of this regimen in these patients.
Determine the optimal dose of paclitaxel when administered in this regimen in these patients.
Determine the effect of tumor tubulin isoform expression on chemosensitivity and overall survival of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses.

Beginning 3 weeks after completion of initial chemotherapy, patients receive concurrent chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29; fluorouracil IV continuously for 5 weeks; and radiotherapy daily 5 days a week for 5 weeks.

At 4-8 weeks after completion of chemoradiotherapy, patients may undergo surgical resection. Patients with local progressive disease after 2 courses of initial chemotherapy undergo surgical resection instead of receiving concurrent chemoradiotherapy.

Patients are followed within 6 weeks, every 3 months for 3 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Primary Purpose:

Treatment

Official Title:

Phase II Evaluation Of Paclitaxel, Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Jan 1, 2004

Actual Study Completion Date :

Apr 1, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction
Potentially resectable disease
No malignant celiac node involvement
No cervical esophageal carcinoma

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,800/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST no greater than 3 times ULN

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Other:

No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No significant medical or psychiatric illness that would preclude study
Not pregnant or nursing
Fertile patients must use effective contraception during and for at least 3 months after study