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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Pfizer
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Celecoxib; Paclitaxel

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 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