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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Pharmacia
Information provided by (Responsible Party):
Peter C. Enzinger, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00137852
First received: August 29, 2005
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Esophageal Cancer
Drug: Cisplatin
Drug: Irinotecan
Drug: Celecoxib
Procedure: Radiation Therapy
Procedure: Esophagectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the side effects of chemotherapy and radiation therapy in patients with resectable esophageal carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: January 2002
Estimated Study Completion Date: January 2013
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137852

Locations
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
Pharmacia
Investigators
Principal Investigator: Peter C. Enzinger, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00137852     History of Changes
Other Study ID Numbers: 01-229
Study First Received: August 29, 2005
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Esophageal Cancer
Resectable Esophageal Cancer
Radiation Therapy
Celecoxib
Irinotecan
Cisplatin

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Irinotecan
Cisplatin
Celecoxib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014