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Phase II Trial of Cisplatin, CPT-11, Celecoxib (PCC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

Phase II Trial of Cisplatin, CPT-11, Celecoxib (PCC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer

Patients will take celecoxib orally twice daily 3 days prior to radiation therapy and until
one week prior to surgery. Celecoxib will then be restarted when the patient is discharged
from the hospital following surgery and continued for 26 weeks.

Patients will receive chemotherapy (cisplatin and irinotecan) weekly on weeks 1, 2, 4 and 5
during radiation therapy. Chemotherapy must occur on or before the fifth day of radiation

Radiation therapy will be performed 5 days a week over a 5.6 week period.

Patients will undergo an esophagectomy within 4-8 weeks of chemotherapy/radiation therapy.
Technically accessible lymph nodes will also be removed.

During chemotherapy/radiation therapy, a physical exam and bloodwork will be conducted

Between chemotherapy/radiation therapy and surgery a physical exam, bloodwork and CT of
chest, abdomen, and pelvis should be performed.

After the completion of treatment and surgery, a physical exam and bloodwork should be done
every 6 weeks for 6 months, then every 3 months for 1 1/2 years, then every 6 months for 3

Inclusion Criteria:

- Age greater than or equal to 18 years.

- Adenocarcinoma or squamous cell carcinoma of the esophagus, including the
gastroesophageal junction, histologically confirmed, American Joint Committee on
Cancer (AJCC) Stage IIA, IIB, III. Additionally, patients with tumors of the lower
thoracic esophagus and gastroesophageal junction may have regional lymph node
involvement (M1A-Stage IVA), as long as the lymphadenopathy can be entirely
encompassed by the radiation field.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Neutrophils greater than or equal to 1,500/ μL.

- Platelets greater than or equal to 100,000/ μL.

- Serum bilirubin less than or equal to 1.5 mg/dl.

- Serum creatinine less than or equal to 1.5 mg/dl.

- Aspartamine transaminase (AST or SGOT) less than or equal to 3x upper institutional
normal limit.

- Alkaline phosphatase less than or equal to 5x upper institutional normal limit.

Exclusion Criteria:

- No prior surgery for esophageal or gastro-esophageal junction cancer.

- No prior chemotherapy or radiation therapy.

- Biopsy proven tumor invasion of the tracheobronchial tree or a tracheoesophageal

- Metastatic disease to distant organs (e.g. liver, lungs, bone) or non-regional lymph
nodes. Patients with supraclavicular/cervical lymph node involvement or patients
with a proximal esophageal primary and celiac/gastro-hepatic lymph node involvement
are also excluded.

- Patients with co-morbid disease that, in the opinion of the investigator, makes
combined chemo-radiotherapy inadvisable (e.g. New York State Grade III-IV heart
disease, myocardial infarction in the last 4 months, uncontrolled infection,
uncontrolled diabetes, uncontrolled hypertension, uncontrolled psychiatric illness or
organ allograft(s) on immunosuppressive therapy).

- Pregnant or lactating women or women of childbearing potential with either a positive
or no pregnancy test at baseline.

- Women of childbearing potential not using a reliable and appropriate contraceptive
method. (Postmenopausal women must have been amenorrheic for at least 12 months to
be considered of non-childbearing potential.)

- Other active malignancy (i.e. hematologic malignancy, metastatic solid tumor, or
resected Stage I-IV solid tumor less than 3 years after resection).

- Patients with known Gilbert's disease or interstitial pulmonary fibrosis.

- Patients with prior severe reaction to nonsteroidal anti-inflammatory drugs (NSAIDs),
sulfonamides, or celecoxib.

- Patients with a history of seizure disorders who are receiving antiepileptic

- Positive malignant cytology of the pleura, pericardium or peritoneum.

- Uncontrolled diarrhea (National Cancer Institute Common Toxicity Criteria [NCI CTC]
greater than or equal to Grade 2).

- Peripheral neuropathy (NCI CTC greater than or equal to Grade 2).

- Symptomatic hearing loss, requiring a hearing aid or for which a hearing aid has been
suggested by a health professional.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma

Outcome Time Frame:


Safety Issue:


Principal Investigator

Peter C. Enzinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2002

Completion Date:

January 2013

Related Keywords:

  • Esophageal Cancer
  • Esophageal Cancer
  • Resectable Esophageal Cancer
  • Radiation Therapy
  • Celecoxib
  • Irinotecan
  • Cisplatin
  • Esophageal Diseases
  • Esophageal Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617