COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00137852
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : September 20, 2017
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Peter C. Enzinger, MD, Dana-Farber Cancer Institute

Brief Summary:
This is a study for patients with resectable, locally advanced esophageal cancer. There is evidence to suggest that celecoxib in combination with cisplatin and irinotecan (CPT-11) may work well with radiation therapy to kill cancer cells. The primary goal is to develop a well-tolerated cancer treatment that has an acceptable response rate.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Cisplatin Drug: Irinotecan Drug: Celecoxib Procedure: Radiation Therapy Procedure: Esophagectomy Phase 2

Detailed Description:

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 therapy.

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 weekly.

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 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Cisplatin, CPT-11, Celecoxib (PCC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
Study Start Date : January 2002
Actual Primary Completion Date : August 2004
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Cisplatin/CPT-11/Celecoxib/XRT/Surgery
Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer
Drug: Cisplatin
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy.

Drug: Irinotecan
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy
Other Name: CPT-11

Drug: Celecoxib
Given twice daily 3 days prior to radiation and up until one week prior to surgery. It will then be started again once the participant is released from the hospital following surgery for 26 weeks.

Procedure: Radiation Therapy
5 days a week for 5-6 weeks

Procedure: Esophagectomy
Within 4-8 weeks of chemoradiation therapy

Primary Outcome Measures :
  1. Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma

Secondary Outcome Measures :
  1. Determine the side effects of chemotherapy and radiation therapy in patients with resectable esophageal carcinoma [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 fistula.
  • 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 medication.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00137852

Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Layout table for investigator information
Principal Investigator: Peter C. Enzinger, MD Dana-Farber Cancer Institute
Publications of Results:
Layout table for additonal information
Responsible Party: Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00137852    
Other Study ID Numbers: 01-229
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Keywords provided by Peter C. Enzinger, MD, Dana-Farber Cancer Institute:
Esophageal Cancer
Resectable Esophageal Cancer
Radiation Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors