Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Temple University Health System (TUHS)

Status and phase

Completed

Phase 2

Conditions

Esophageal Cancer

Treatments

Procedure: neoadjuvant therapy

Drug: cisplatin

Radiation: radiation therapy

Procedure: conventional surgery

Drug: paclitaxel

Drug: fluorouracil

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00021320

P30CA006927 (U.S. NIH Grant/Contract)

FCCC-00003

NCI-G01-1982

CDR0000068769

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

PRIOR CONCURRENT THERAPY:

Biologic therapy: