Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer
NCT ID: NCT00137852
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2002-01-31
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cisplatin/CPT-11/Celecoxib/XRT/Surgery
Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer
Cisplatin
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy.
Irinotecan
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy
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.
Radiation Therapy
5 days a week for 5-6 weeks
Esophagectomy
Within 4-8 weeks of chemoradiation therapy
Interventions
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Cisplatin
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy.
Irinotecan
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy
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.
Radiation Therapy
5 days a week for 5-6 weeks
Esophagectomy
Within 4-8 weeks of chemoradiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Pharmacia
INDUSTRY
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Peter C. Enzinger, MD
Principal Investigator
Principal Investigators
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Peter C. Enzinger, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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Cleary JM, Mamon HJ, Szymonifka J, Bueno R, Choi N, Donahue DM, Fidias PM, Gaissert HA, Jaklitsch MT, Kulke MH, Lynch TP, Mentzer SJ, Meyerhardt JA, Swanson RS, Wain J, Fuchs CS, Enzinger PC. Neoadjuvant irinotecan, cisplatin, and concurrent radiation therapy with celecoxib for patients with locally advanced esophageal cancer. BMC Cancer. 2016 Jul 13;16:468. doi: 10.1186/s12885-016-2485-9.
Other Identifiers
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01-229
Identifier Type: -
Identifier Source: org_study_id