Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

Basic Trial Information

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

Objectives

1. 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.
2. Compare the clinical response rate in patients treated with these regimens.
3. Compare chemotherapy-related toxicity in patients treated with these regimens.
4. Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer
  • Stage IIIA
  • Must have N2 disease by mediastinoscopy



• Potentially resectable

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 80-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Rates of complete pathological response and/or minimal residual microscopic disease at 3 years

Clinical response at 3 years
Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Karen Rickard, MD, Principal investigator		Ph: 310-825-5788; 888-798-0719

Registry Information
Official Title		A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer
Trial Start Date		2003-03-05
Registered in ClinicalTrials.gov		NCT00062179
Date Submitted to PDQ		2003-04-29
Information Last Verified		2007-04-11
NCI Grant/Contract Number		CA16042

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