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


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

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


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.

Inclusion 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:

- 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jonathan Cheng, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068769

NCT ID:

NCT00021320

Start Date:

May 2000

Completion Date:

April 2009

Related Keywords:

  • Esophageal Cancer
  • stage 0 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

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111