search
Back to results

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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Irinotecan
Celecoxib
Radiation Therapy
Esophagectomy
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Resectable Esophageal Cancer, Radiation Therapy, Celecoxib, Irinotecan, Cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cisplatin/CPT-11/Celecoxib/XRT/Surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Determine the side effects of chemotherapy and radiation therapy in patients with resectable esophageal carcinoma

Full Information

First Posted
August 29, 2005
Last Updated
September 18, 2017
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Pharmacia
search

1. Study Identification

Unique Protocol Identification Number
NCT00137852
Brief Title
Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer
Official Title
Phase II Trial of Cisplatin, CPT-11, Celecoxib (PCC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Pharmacia

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal Cancer, Resectable Esophageal Cancer, Radiation Therapy, Celecoxib, Irinotecan, Cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin/CPT-11/Celecoxib/XRT/Surgery
Arm Type
Experimental
Arm Description
Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
CPT-11
Intervention Description
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Intervention Description
5 days a week for 5-6 weeks
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy
Intervention Description
Within 4-8 weeks of chemoradiation therapy
Primary Outcome Measure Information:
Title
Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma
Secondary Outcome Measure Information:
Title
Determine the side effects of chemotherapy and radiation therapy in patients with resectable esophageal carcinoma
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C. Enzinger, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27412386
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs