Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Other	CDR0000304540 UCLA-0208074, NYH-CMC-0902-464, PHARMACIA-COXAON-0509-106, NCT00062179

Trial Description

Summary

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, may stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib before surgery may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer.

Further Study Information

OBJECTIVES:

• Compare the complete pathological response rate and/or minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib.

• Compare the clinical response rate in patients treated with these regimens.

• Compare chemotherapy-related toxicity in patients treated with these regimens.

• Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to use of aspirin for prior cardiovascular disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: 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 on day 1 and continuing until the morning of surgical resection.

• Arm II: Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection.

In both arms, patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy. Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3-6 months.

PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

• Stage IIIA

• Must have N2 disease by mediastinoscopy

• Potentially resectable

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/or 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 participation

Pulmonary

• Pulmonary function acceptable for surgery

• No interstitial pneumonia

• No interstitial fibrosis

Gastrointestinal

• No bowel obstruction within the past 5 years

• No history of peptic ulcer disease

• No irritable bowel disease

• No inflammatory bowel syndrome

• No chronic diarrhea

Immunologic

• No uncontrolled infection (including HIV)

• No known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates

• No hypersensitivity to paclitaxel

Other

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 1 month after study participation

• No uncontrolled diabetes mellitus

• No significant psychiatric illness that would preclude study compliance

• No other serious underlying medical condition that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• No concurrent chronic steroids, except inhaled mometasone or fluticasone

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs)

• More than 3 weeks since other prior clinical trial therapy

• Concurrent low-dose aspirin (less than 325 mg every other day) for cardiovascular disease prophylaxis allowed

• No concurrent NSAIDs, including chronic use

• No concurrent cyclo-oxygenase-2 (COX-2) inhibitors

• No other concurrent investigational agents

• No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin or phenobarbital)

• No concurrent lithium

• No concurrent fluconazole

Trial Contact Information

Trial Lead Organizations/Sponsors

Jonsson Comprehensive Cancer Center at UCLA

Karen Rickard

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00062179
Information obtained from ClinicalTrials.gov on October 19, 2009

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