Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Status: | Terminated |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/25/2018 |
Start Date: | February 2010 |
End Date: | March 2018 |
A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin,
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor
cells by blocking some of the enzymes needed for cell growth. It is not yet known whether
giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more
effective with or without celecoxib in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed
disodium, and carboplatin to compare how well they work when given together with celecoxib or
a placebo in treating patients with advanced non-small cell lung cancer.
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor
cells by blocking some of the enzymes needed for cell growth. It is not yet known whether
giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more
effective with or without celecoxib in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed
disodium, and carboplatin to compare how well they work when given together with celecoxib or
a placebo in treating patients with advanced non-small cell lung cancer.
OBJECTIVES:
Primary
- To confirm the beneficial effect of gemcitabine hydrochloride or pemetrexed disodium in
combination with carboplatin with or without celecoxib in patients with advanced
non-small cell lung cancer that expresses COX-2.
Secondary
- To describe the response rate in patients treated with these regimens.
- To describe the distribution of progression-free survival (PFS) and overall survival of
patients treated with these regimens.
- To compare the PFS of patients with COX-2 index ≥ 2 (adjusting for CYP2C9 genotype and
celecoxib trough concentrations as covariates) treated with these regimens.
- To correlate urinary PGE-M level with COX-2 expression, COX-2 inhibition, and outcome.
- To evaluate the association between the -765G/C polymorphism in PTGS2 and COX-2
expression in non-small cell lung cancer specimens.
- To characterize a trough plasma celecoxib concentration which will be used as a measure
of patient adherence to study treatment and which may be used in future studies for
correlations with genotype and pharmacodynamic outcomes.
OUTLINE: This is a multicenter study. Patients are stratified according to gender, disease
stage (IIIB vs IV), histology (squamous cell carcinoma vs non-squamous cell carcinoma),
smoking status (never/former light smoker [defined as ≤ 10 pack years AND quit ≥ 1 year ago]
vs smoker), and COX-2 expression status (COX-2 index ≥ 4 vs COX-2 index ≥ 2 but < 4).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride* IV on days 1 and 8 OR pemetrexed
disodium* IV on day 1. Patients also receive carboplatin IV on day 1 and oral celecoxib
twice daily on days 1-21.
- Arm II: Patients receive gemcitabine hydrochloride* OR pemetrexed disodium* and
carboplatin as in arm I. Patients also receive oral placebo twice daily on days 1-21.
- NOTE: *Patients with squamous cell carcinoma receive gemcitabine hydrochloride; patients
with non-squamous cell carcinoma receive pemetrexed disodium.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity. After completion of 6 courses, patients with responding
or stable disease may continue to receive celecoxib or placebo alone in the absence of
disease progression or unacceptable toxicity.
Patients may undergo blood and urine sample collection periodically for correlative
laboratory studies.
After completion of study therapy, patients are followed up every 2 months for 2 years and
then every 6 months for 3 years.
Primary
- To confirm the beneficial effect of gemcitabine hydrochloride or pemetrexed disodium in
combination with carboplatin with or without celecoxib in patients with advanced
non-small cell lung cancer that expresses COX-2.
Secondary
- To describe the response rate in patients treated with these regimens.
- To describe the distribution of progression-free survival (PFS) and overall survival of
patients treated with these regimens.
- To compare the PFS of patients with COX-2 index ≥ 2 (adjusting for CYP2C9 genotype and
celecoxib trough concentrations as covariates) treated with these regimens.
- To correlate urinary PGE-M level with COX-2 expression, COX-2 inhibition, and outcome.
- To evaluate the association between the -765G/C polymorphism in PTGS2 and COX-2
expression in non-small cell lung cancer specimens.
- To characterize a trough plasma celecoxib concentration which will be used as a measure
of patient adherence to study treatment and which may be used in future studies for
correlations with genotype and pharmacodynamic outcomes.
OUTLINE: This is a multicenter study. Patients are stratified according to gender, disease
stage (IIIB vs IV), histology (squamous cell carcinoma vs non-squamous cell carcinoma),
smoking status (never/former light smoker [defined as ≤ 10 pack years AND quit ≥ 1 year ago]
vs smoker), and COX-2 expression status (COX-2 index ≥ 4 vs COX-2 index ≥ 2 but < 4).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride* IV on days 1 and 8 OR pemetrexed
disodium* IV on day 1. Patients also receive carboplatin IV on day 1 and oral celecoxib
twice daily on days 1-21.
- Arm II: Patients receive gemcitabine hydrochloride* OR pemetrexed disodium* and
carboplatin as in arm I. Patients also receive oral placebo twice daily on days 1-21.
- NOTE: *Patients with squamous cell carcinoma receive gemcitabine hydrochloride; patients
with non-squamous cell carcinoma receive pemetrexed disodium.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity. After completion of 6 courses, patients with responding
or stable disease may continue to receive celecoxib or placebo alone in the absence of
disease progression or unacceptable toxicity.
Patients may undergo blood and urine sample collection periodically for correlative
laboratory studies.
After completion of study therapy, patients are followed up every 2 months for 2 years and
then every 6 months for 3 years.
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell carcinoma of the lung,
including the following cell types:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Mixture of these types
- A tissue block must be available at the time of registration
- Tumor expresses COX-2 (COX-2 index ≥ 2)
- Stage IIIB disease with malignant pleural effusion, supraclavicular node involvement,
or contralateral hilar node involvement OR stage IV disease
- Patients with stage IIIB disease who are eligible for clinical trials that
involve combined chemotherapy and chest irradiation are not eligible for this
study
- Patients with stage IV disease are eligible
- Patients with recurrent disease, not amenable to (or refusing) a potentially "curative
therapy," are eligible
- Measurable or non-measurable disease
- Measurable disease is defined as lesions that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded) as ≥ 2 cm with conventional
techniques or as ≥ 1 cm with spiral CT scan
- Non-measurable disease is defined as all other lesions, including small lesions
(longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT
scan) and truly nonmeasurable lesions, including any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Patients with symptomatic CNS metastases are eligible provided they received prior
therapy (e.g., surgery, radiotherapy, or gamma knife), are neurologically stable, and
are off steroids for ≥ 14 days before study entry
- Patients with asymptomatic CNS metastases without associated edema, shift, or
requirement for steroids or antiseizure medications may be eligible after
discussion with the Study Chair
- Patients should be off steroids at least 7 days before preregistration
- No leptomeningeal disease or carcinomatous meningitis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Granulocytes ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Creatinine clearance ≥ 45 mL/min
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.0 times upper limit of normal (ULN) (≤ 5.0 times ULN if liver
metastases are present)
- Serum albumin ≥ 2.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- No "currently active" second malignancy other than non-melanoma skin cancer
- Patients are not considered to have a "currently active" malignancy if they have
completed therapy and are considered by their physician to be at < 30% risk of
relapse
- No known hypersensitivity to aspirin, NSAIDs, or sulfonamides
- No active ulcer disease
- No history of gastrointestinal bleeding within the past three years
- None of the following cardiovascular conditions within the past 6 months:
- Myocardial infarction
- Unstable angina
- Symptomatic congestive heart failure
- Serious uncontrolled cardiac arrhythmia
- Cerebrovascular accident or transient ischemic attack
- Pulmonary embolism
- Symptomatic carotid artery or peripheral vascular disease
- Deep vein thrombosis
- Other significant thromboembolic event
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy, immunotherapy, or other systemic therapy for non-small cell
lung cancer, including adjuvant therapy
- At least 2 weeks since prior surgery and recovered
- At least 7 days since prior radiotherapy
- At least 14 days since prior NSAIDs (other than low-dose aspirin [≤ 325 mg daily]),
including any of the following:
- Celecoxib
- Choline Mg
- Trisalicylate (Trilisate®)
- Ibuprofen (Advil® or Motrin®)
- Naproxen (Aleve®, Naprosyn® or Anaprox®)
- Etodolac (Lodine®)
- Oxaprozin (Daypro®)
- Diflunisal (Dolobid®)
- Nabumetone (Relafen®)
- Tolmetin (Tolectin®)
- Valdecoxib (Bextra®)
- No chronic use of NSAIDs (i.e., > 4 weeks of daily use)
- Patients on low-dose aspirin are eligible
- No other concurrent chemotherapy or hormonal therapy (other than megestrol acetate
[Megace] for appetite stimulation)
- No other concurrent investigational therapy
We found this trial at
409
sites
1200 Old York Road
Abington, Pennsylvania 19001
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(215) 481-2400
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417 State St #30
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115 Business loop 70 w
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1900 South Avenue
La Crosse, Wisconsin 54601
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One Medical Center Drive
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425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
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1415 E. Kincaid
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1300 York Avenue # A421
New York, New York 10065
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800 NE 10th Street
Oklahoma City, Oklahoma 73104
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19500 10th Ave NE # 100
Poulsbo, Washington 98370
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593 Eddy Street
Providence, Rhode Island 02903
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1600 Divisadero Street
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4700 Waters Avenue
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747 Broadway
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1959 NE Pacific St
Seattle, Washington 98195
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1100 Fairview Avenue North
Seattle, Washington 98109
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601 South Sherman Street
Spokane, Washington 99202
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(509) 228-1000
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
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1211 24th Street
Anacortes, Washington 98221
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
1.877.590.5995
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4950 Essen Ln
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
(225) 767-0847
![Mary Bird Perkins Cancer Center - Baton Rouge](/wp-content/uploads/logos/mary-bird-perkins-cancer-center---baton-rouge.jpg)
Mary Bird Perkins Cancer Center - Baton Rouge Mary Bird Perkins Cancer Center (MBPCC) and...
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300 North Ave
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
(269) 245-8000
![Battle Creek Health System Cancer Care Center](/wp-content/uploads/logos/battle-creek-health-system-cancer-care-center.png)
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
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St. Joseph Cancer Center The PeaceHealth St. Joseph Cancer Center offers a full-range of services...
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1351 Kimberly Rd
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
(563) 355-7733
![Hematology Oncology Associates of the Quad Cities](/wp-content/uploads/logos/hematology-oncology-associates-of-the-quad-cities.jpg)
Hematology Oncology Associates of the Quad Cities
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Mecosta County Medical Center Spectrum Health is a not-for-profit system of care dedicated to improving...
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1101 N 27th St # 201
Billings, Montana 59101
Billings, Montana 59101
(406) 237-3585
![St. Vincent Healthcare Cancer Care Services](/wp-content/uploads/logos/st-vincent-healthcare-cancer-care-services.jpg)
St. Vincent Healthcare Cancer Care Services The Sisters of Charity of Leavenworth, Kansas, founded St....
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2900 12th Ave N Ste 160W
Billings, Montana 59101
Billings, Montana 59101
(406) 238-6290
![Hematology-Oncology Centers of the Northern Rockies - Billings](/wp-content/uploads/logos/hematology-oncology-centers-of-the-northern-rockies---billings.jpg)
Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
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900 East Broadway
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
701.530.7000
![St. Alexius Medical Center Cancer Center](/wp-content/uploads/logos/st-alexius-medical-center-cancer-center.gif)
St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
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Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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720 E Rosser Ave
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6741
![Medcenter One Hospital Cancer Care Center](/wp-content/uploads/logos/medcenter-one-hospital-cancer-care-center.jpg)
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
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Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
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1055 N Curtis Rd
Boise, Idaho 83706
Boise, Idaho 83706
(208) 367-2121
![Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center](/wp-content/uploads/logos/saint-alphonsus-cancer-care-center-at-saint-alphonsus-regional-medical-center.jpg)
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Saint Alphonsus Health System...
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1501 North Oakland Drive
Bolivar, Missouri 65613
Bolivar, Missouri 65613
417-326-7200
![Central Care Cancer Center at Carrie J. Babb Cancer Center](/wp-content/uploads/logos/central-care-cancer-center-at-carrie-j-babb-cancer-center.png)
Central Care Cancer Center at Carrie J. Babb Cancer Center Cancer treatment often requires a...
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72 East Concord St.
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617-638-4173
![Boston University Cancer Research Center](/wp-content/uploads/logos/boston-university-cancer-research-center.gif)
Boston University Cancer Research Center
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Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
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Bozeman Deaconess Cancer Center Bozeman Deaconess Cancer Center provides the latest cancer technologies and treatment...
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16233 Sylvester Rd SW #110
Burien, Washington 98166
Burien, Washington 98166
(206) 439-5577
![Highline Medical Center Cancer Center](/wp-content/uploads/logos/highline-medical-center-cancer-center.jpg)
Highline Medical Center Cancer Center At Highline Cancer Center, we recognize that cancer doesn't just...
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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St. James Healthcare Cancer Care The St. James Cancer Center is an integrated cancer treatment...
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Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
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701 10th St SE
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
(319) 365-4673
![Mercy Regional Cancer Center at Mercy Medical Center](/wp-content/uploads/logos/mercy-regional-cancer-center-at-mercy-medical-center.gif)
Mercy Regional Cancer Center at Mercy Medical Center Hall-Perrine Cancer Center is a part of...
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Providence Centralia Hospital We are a 127-bed, not for profit hospital providing emergency, diagnostic, cancer,...
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
Chicago, Illinois 60612
312.355.1625
![University of Illinois Cancer Center](/wp-content/uploads/logos/university-of-illinois-cancer-center.jpg)
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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