0822GCC: Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Lung Cancer, Non Small Cell Lung Cancer

In brief

The primary objective is to determine the anti-tumor activity of the combination of apricoxib + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel (P/DC) or pemetrexed (P/PE) as measured by progression free survival in patients with Stage IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).

Key facts

Study ID

NCT00771953

Run by

University of Maryland, Baltimore

People needed

109

Starts

2008-11-01

Expected to finish

2014-12-01

Last updated by the study team

2019-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically determined stage IV non-small cell lung cancer (NSCLC), including stage IIIb (pleural effusion) (histology or cytology acceptable).
• Documented progression after 1 prior platinum-based chemotherapy. No more than one prior chemotherapy regimen is permitted. Patients may have also received erlotinib (before, after or concurrently with platinum based therapy).
• Measurable disease by RECIST criteria
• Age at least 18 years.
• ECOG performance status of 0-2.
• Required Laboratory Values (within 28 days before randomization) :
• Hb ≥ 9.0gm/dL; transfusions permitted
• ANC ≥ 1500/mm3
• Platelets ≥ 100,000/mm3
• INR ≤ 1.5
• Serum creatinine (Cr) within normal limits for laboratory OR Creatinine clearance greater than or equal to 45 ml/min. 24 hour measured CCr is also acceptable (calculated by the Cockcroft and Gault equation).
• SGOT and SGPT < 2 X the ULN; if liver metastases are present then must be < 5 X the ULN
• Bilirubin ≤ Institutional ULN
• Albumin ≥ or equal to 2.5 mg/dl
• May have been treated with anti-EGFR kinase therapy in addition to a platinum based therapy or concurrently with platinum therapy.
• Provide written informed consent and HIPAA authorization and agree to abide by the study restrictions and return for the required assessments.
• Women of child-bearing potential must have negative pregnancy test (serum B-HCG) with a sensitivity of at least 50 mIU/L within 7 days prior to the initiation of treatment and must have used effective contraception (recommended to be two reliable forms of contraception used simultaneously) or must have been sexually abstinent for at least 4 weeks prior to the negative pregnancy test through entry in the study.
• Female patients and male patients with female partners of child-bearing potential must agree to sexual abstinence or to practice effective contraception (recommended to be two reliable forms of contraception used simultaneously). At least one non-hormonal method strongly recommended. Male patients with female sexual partners who are pregnant, or of childbearing potential must agree to use condoms during and for at least 1 month after the last dose of apricoxib.

You may not qualify if…

• Pregnant or breast feeding
• Known hypersensitivity to apricoxib, docetaxel, other drugs formulated with polysorbate 80, pemetrexed, sulfonamides, aspirin, or other NSAIDs.
• Radiation therapy within 2 weeks or chemotherapy within 3 weeks or non-cytotoxic investigational agents within 3 weeks of initiating study treatment or patients who have not recovered from adverse effects due to agents administered > 3 weeks prior to initiating study treatment. Screening for urinary PGE-M suppression may begin during this time period.
• Evidence of New York Heart Association class III or greater cardiac disease. History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months.
• Concurrent severe or uncontrolled medical disease that could compromise the safety of the patient or compromise the ability of the patient to complete the study.
• Known HIV infection or AIDS. Testing not required.
• Symptomatic central nervous system metastases; the patient must be stable after radiotherapy for ≥ 2 weeks. Patients must be off all steroid or antiseizure medications for this indication for ≥ 2 weeks. Patients with CNS metastases that are untreated are eligible if there is no evidence of midline shift, requirement for steroids or antiseizure medications or neurologic symptoms.
• History of upper GI bleeding, ulceration, or perforation within the past 5 years.
• Concurrent use of COX-2 inhibitors or other NSAIDs for 2 days prior to the first dose of study treatment and during study, including aspirin for 7 days prior to the first dose of study treatment and during study.
• Previous COX-2 inhibitor therapy for this diagnosis.

Where it is running

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Mercy Research Institute — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Weill Medical Cornell University — New York, New York, United States
• Stony Brook Cancer Center (SUNY) — Stony Brook, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Abramson Cancer Center of Uof Pennsylvania — Philadelphia, Pennsylvania, United States
• West Virginia University Clinical Trials Research Unit — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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