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Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus Clinical research trials and Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus. Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus clinical trial. Participants frequently obtain the most expert healthcare available for their Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus  Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
For Condition: stage 2 esophageal cancer,squamous cell carcinoma of the esophagus,stage 3 esophageal cancer,stage 1 esophageal cancer,Adenocarcinoma of the Esophagus
Status: Recruiting
Sponsor(s): Cornell University Medical College ,
Synopsis: RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use 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 tumor cell 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: Phase II trial to study the effectiveness of celecoxib combined with paclitaxel and carboplatin in treating patients who are undergoing surgery for esophageal cancer.
Details: OBJECTIVES: - Determine the rate of complete pathological response and/or minimal residual microscopic disease in patients with squamous cell or adenocarcinoma of the esophagus treated with preoperative celecoxib, paclitaxel, and carboplatin. - Determine the clinical response rate of patients treated with this regimen. - Determine the chemotherapy-related toxicity of this regimen in these patients. - Determine the time to progression, disease-free survival, and overall survival of patients treated with this regimen. OUTLINE: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1 and 22. Patients also receive oral celecoxib twice daily beginning 3-7 days before the first dose of chemotherapy and continuing until the morning of planned surgical resection (between day 36 and 50). Approximately 28-42 days after resection, patients resume oral celecoxib twice daily and continue for 3 years in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 no greater than upper limit of normal (ULN) - AST and ALT less than 2.5 times 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 disease - No inflammatory bowel syndrome - 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 COX-2 inhibitors - No concurrent lithium or fluconazole - Concurrent low-dose aspirin (325 mg/day or less) allowed for cardiovascular prophylaxis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NasserAltorki, Study Chair, Cornell University Medical College
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Nasser Altorki 212-746-4528
Additional Information:
Study ID Numbers: CDR0000316464; NYWCCC-0902-463
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066716
Other Stage 2 Esophageal Cancer Studies:
1. Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
2. Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
3. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
4. Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
5. BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With Chemotherapy
Related Studies:
Other stage 2 esophageal cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
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