Esophageal Cancer Clinical Trial
Official title:
A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New York Weill Cornell Cancer Center at Cornell University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathological response rate at time of surgical resection | At completion of pathology report. | No | |
Secondary | Clinical response rate | At the time of tumor assessment obtained prior to definitive surgery approximately 1-2 weeks prior to surgical resection. | No | |
Secondary | Disease-free survival | From start of treatment to time of recurrent disease measured postoperatively every 6 months for 18 months. | No | |
Secondary | Overall survival | 18 months after surgery | No | |
Secondary | Toxicities and safety | 30 days after completion of study treatment. | Yes |
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