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

NCT00137852 | Completed Phase 2

• 1 other identifier: 01-229
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Resectable Esophageal Cancer; Radiation Therapy; Celecoxib; Irinotecan; Cisplatin

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

  2 years

Study Arms (1)

Cisplatin/CPT-11/Celecoxib/XRT/Surgery

EXPERIMENTAL

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

Drug: Cisplatin; Drug: Irinotecan; Drug: Celecoxib; Procedure: Radiation Therapy; Procedure: Esophagectomy

Interventions

Cisplatin DRUG

Given weekly on weeks 1, 2, 4 and 5 during radiation therapy.

Cisplatin/CPT-11/Celecoxib/XRT/Surgery

Irinotecan DRUG

Given weekly on weeks 1, 2, 4 and 5 during radiation therapy

Also known as: CPT-11

Cisplatin/CPT-11/Celecoxib/XRT/Surgery

Celecoxib DRUG

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.

Cisplatin/CPT-11/Celecoxib/XRT/Surgery

Radiation Therapy PROCEDURE

5 days a week for 5-6 weeks

Cisplatin/CPT-11/Celecoxib/XRT/Surgery

Esophagectomy PROCEDURE

Within 4-8 weeks of chemoradiation therapy

Cisplatin/CPT-11/Celecoxib/XRT/Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Pharmacia: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 27412386 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cisplatin; Irinotecan; Celecoxib; Radiotherapy; Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Peter C. Enzinger, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: January 1, 2002
• Primary Completion: August 1, 2004
• Study Completion: September 1, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

US (2)