NCT01041781|TerminatedPhase 3ResultsDMC

Study Stopped

DSMB recommendation

Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

CALGB-30801CDR0000662707

Study Type

interventional

Target

313

Locations

1 country

Sites

400

Timeline

RegisteredJan 2010

StartedFeb 2010

CompletionMar 2018

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

313

participants targeted

Target at P50-P75 for phase_3 lung-cancer

Timeline

Completed

Started Feb 2010

Longer than P75 for phase_3 lung-cancer

Geographic Reach

1 country

400 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.1 years study duration

First Submitted

Initial submission to the registry

December 31, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2010

Completed

1 month until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed

7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2017

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed

5 months until next milestone

Results Posted

Study results publicly available

July 23, 2018

Completed

Last Updated

July 23, 2018

Status Verified

June 1, 2018

Enrollment Period

7 years

First QC Date

December 31, 2009

Results QC Date

June 26, 2018

Last Update Submit

June 26, 2018

Conditions

Lung Cancer

Keywords

adenocarcinoma of the lungadenosquamous cell lung cancerlarge cell lung cancersquamous cell lung cancerrecurrent non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Progression-free Survival
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time between randomization and disease relapse or death from any cause, assessed up to 5 years

Secondary Outcomes (6)

Overall Survival
Time between randomization and death from any cause, assessed up to 5 years
Response Rate
Up to 5 years
Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0
Up to 5 years
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1)
Up to 5 years
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2)
Up to 5 years
+1 more secondary outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

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.

Drug: carboplatinDrug: celecoxibDrug: gemcitabine hydrochlorideDrug: pemetrexed disodium

Arm II

ACTIVE COMPARATOR

Patients receive gemcitabine hydrochloride\* OR pemetrexed disodium\* and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 1-21.

Drug: carboplatinDrug: gemcitabine hydrochlorideDrug: pemetrexed disodiumOther: placebo

Interventions

carboplatinDRUG

Given IV

Arm IArm II

celecoxibDRUG

Given orally

Arm I

gemcitabine hydrochlorideDRUG

Given IV

Arm IArm II

pemetrexed disodiumDRUG

Given IV

Arm IArm II

placeboOTHER

Given orally

Arm II

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (400)

Regional Medical Center

Anniston, Alabama, 36207, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

NEA Medical Clinic - East Matthews

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Camino Medical Group - Treatment Center

Mountain View, California, 94040, United States

Location

Palo Alto Medical Foundation-Camino Division

Mountain View, California, 94040, United States

Location

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Feather River Hospital Cancer Center

Paradise, California, 95969, United States

Location

PCR Oncology

Pismo Beach, California, 93449, United States

Location

Naval Medical Center - San Diego

San Diego, California, 92134, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Front Range Cancer Specialists

Fort Collins, Colorado, 80528, United States

Location

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Middlesex Hospital Cancer Center

Middletown, Connecticut, 06457, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Veterans Affairs Medical Center - Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

North Broward Medical Center

Deerfield Beach, Florida, 33064-3596, United States

Location

Florida Hospital - Orlando

Orlando, Florida, 32803, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

Dwight David Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905-5650, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Cancer Research Center of Hawaii