Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI FCCC-00003 NCI-G01-1982, NCT00021320

Objectives

1. 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.
2. Determine the complete and partial responses in patients treated with this regimen.
3. Assess the toxicity of this regimen in these patients.
4. Determine the optimal dose of paclitaxel when administered in this regimen in these patients.
5. Determine the effect of tumor tubulin isoform expression on chemosensitivity and overall survival of patients treated with this regimen.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for esophageal cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior thoracic radiotherapy

Surgery:

• See Disease Characteristics
• No prior surgical resection of esophageal tumor

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,800/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center - Philadelphia

Jonathan Cheng, MD, Protocol chair		Ph: 215-728-7083; 888-369-2427

Registry Information
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
Trial Start Date		2000-05-03
Registered in ClinicalTrials.gov		NCT00021320
Date Submitted to PDQ		2001-05-29
Information Last Verified		2004-04-08
NCI Grant/Contract Number		P30-CA06927

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