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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00066716

Collaborator

Pfizer (Industry)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: carboplatin Drug: celecoxib Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Pathological response rate at time of surgical resection [At completion of pathology report.]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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