Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus

NCT00066716 | Completed Phase 2

• 2 other identifiers: CDR0000316464NYWCCC-0902-463
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Celecoxib may also stop the growth of tumor cells by stopping blood flow to the tumor and/or may block the enzymes necessary for their growth. Combining celecoxib with paclitaxel and carboplatin before surgery may shrink the tumor so that it can be removed during surgery. Giving celecoxib alone after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving celecoxib together with paclitaxel and carboplatin works in treating patients who are undergoing surgery for esophageal cancer.

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage I esophageal cancer; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer (lymph node metastasis only)

Outcome Measures

Primary Outcomes (1)

• Pathological response rate at time of surgical resection

  At completion of pathology report.

Secondary Outcomes (4)

• Clinical response rate

  At the time of tumor assessment obtained prior to definitive surgery approximately 1-2 weeks prior to surgical resection.

• Disease-free survival

  From start of treatment to time of recurrent disease measured postoperatively every 6 months for 18 months.

• Overall survival

  18 months after surgery

• Toxicities and safety

  30 days after completion of study treatment.

Interventions

carboplatin DRUG

Dosed to an AUC of 6 by the Calvert formula, intravenously over 1 hour after paclitaxel on days 1, 22, and 43.

celecoxib DRUG

400 mg orally BID begins 3-7 days before the first dose of chemotherapy to the morning of surgery. Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year total, that is, 1 year from the date of surgery + 2 weeks unless tumor recurrence is documented.

Also known as: Celebrex

paclitaxel DRUG

200 mg/m2 as a 3-hour intravenous infusion on days 1, 22, and 43.

Also known as: Taxol

adjuvant therapy PROCEDURE

1. Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin. 2. Operation will be performed within 6-12 hours from the last dose of celecoxib. 3. Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection. 4. Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year.

conventional surgery PROCEDURE

1. Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin. 2. Operation will be performed within 6-12 hours from the last dose of celecoxib. 3. Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection.

neoadjuvant therapy PROCEDURE

1. Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin. 2. Operation will be performed within 6-12 hours from the last dose of celecoxib. 3. Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection.

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed esophageal cancer of 1 of the following cellular types: * Squamous cell * Adenocarcinoma * Potentially resectable disease * No distant metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 80-100% Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * No bleeding disorder Hepatic * Bilirubin normal * AST and ALT less than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No significant history of unstable cardiovascular disease * No inadequately controlled hypertension * No angina * No myocardial infarction within the past 6 months * No ventricular cardiac arrhythmias requiring medication * No congestive heart failure that would preclude study therapy Pulmonary * Pulmonary function acceptable for surgery * No interstitial pneumonia * No interstitial fibrosis Gastrointestinal * No history of peptic ulcer disease * No irritable bowel syndrome * No inflammatory bowel disease * No chronic diarrhea * No bowel obstruction within the past 5 years Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates * No hypersensitivity to paclitaxel or carboplatin * No other serious underlying medical condition that would preclude study therapy * No significant psychiatric illness that would preclude study compliance * No uncontrolled diabetes mellitus * No uncontrolled infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * No concurrent chronic steroid use except inhaled mometasone or fluticasone Radiotherapy * Not specified Surgery * Not specified Other * More than 3 weeks since other prior clinical trial therapy * At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs) * No concurrent chronic NSAID use (7 or more days of continuous therapy per month OR 3 or more days of therapy per week) * No other concurrent investigational agents * No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin or phenobarbital) * No other concurrent cyclo-oxygenase (COX)-2 inhibitors * No concurrent lithium or fluconazole * Concurrent low-dose aspirin (325 mg/day or less) allowed for cardiovascular prophylaxis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Pfizer: collaborator

Study Sites (1)

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Carboplatin; Celecoxib; Paclitaxel; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Nasser K. Altorki, MD

  Weill Medical College of Cornell University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: June 1, 2003
• Primary Completion: May 1, 2007
• Last Updated: December 8, 2009

Record last verified: 2009-12

Locations

US (1)