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

Sponsor:	Jonsson Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00062179

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: celecoxib Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control
Official Title:	A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

Drug Information available for: Paclitaxel Carboplatin Celecoxib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Rates of complete pathological response and/or minimal residual microscopic disease at 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response at 3 years [ Designated as safety issue: No ]
Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	March 2003

Detailed Description:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062179

Locations

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
United States, New York
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Karen Rickard

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000304540, UCLA-0208074, NYH-CMC-0902-464, PHARMACIA-COXAON-0509-106
Study First Received:	June 5, 2003
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00062179 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Sensory System Agents
Lung Neoplasms
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Celecoxib

Mitosis Modulators
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Carboplatin
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Analgesics, Non-Narcotic
Paclitaxel
Lung Diseases
Tubulin Modulators
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009