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A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus


OBJECTIVES:

Primary

- 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.

Secondary

- 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, 22, and 43. 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 days 64 and 71). Approximately 28-56 days after resection, patients may
resume oral celecoxib twice daily and continue for 1 year in the absence of disease
progression or unacceptable toxicity.

Patients are followed periodically for 18 months after surgery.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 18 months.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological response rate at time of surgical resection

Outcome Time Frame:

At completion of pathology report.

Safety Issue:

No

Principal Investigator

Nasser K. Altorki, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000316464

NCT ID:

NCT00066716

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • 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)
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021