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Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Either Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer Patients
This study is not yet open for participant recruitment.
Verified by University of Maryland, October 2008
Sponsored by: University of Maryland
Information provided by: University of Maryland
ClinicalTrials.gov Identifier: NCT00771953
  Purpose

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 time to disease progression (TTP)in patients with Stage IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).


Condition Intervention Phase
Lung Cancer
Non Small Cell Lung Cancer
Drug: apricoxib
Drug: Placebo
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel Pemetrexed disodium Pemetrexed
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Either Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer Patients

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Time to disease progression (TTP) [ Time Frame: At the time of clinical progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • progression-free survival (PFS) [ Time Frame: At the time of clinical disease progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: January 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Apricoxib plus Docetaxel or Premetrexed (Treating physician will determine chemotherapy drug as per his usual practice).
Drug: apricoxib
Oral apricoxib + docetaxel or pemetrexed
2: Placebo Comparator
Placebo plus Docetaxel or Premetrexed (Treating physician will determine chemotherapy drug as per his usual practice).
Drug: Placebo
Placebo + docetaxel or pemetrexed

  Eligibility

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

Inclusion Criteria:

  • All patients must have 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).
  • Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) at least 20mm for routine CT scan and at least 10mm for spiral CT scan.
  • Age at least 18 years old.
  • ECOG performance status of 0-2.
  • Required Laboratory Values (obtained within 30 days prior to randomization) with the following ranges:
  • Hemoglobin ≥ 9.0gm/dL; transfusions permitted
  • Absolute neutrophil count (ANC) ≥ 1500/mm3
  • Platelet count ≥ 100,000/mm3
  • International normalized ratio (INR) ≤ 1.5
  • Creatinine (Cr) < 2 X the upper limit of normal (ULN)
  • Alanine aminotransferase (SGOT) and aspartate aminotransferase (SGPT) < 2 X the ULN; if liver metastases are present then must be < 5 X the ULN
  • Bilirubin < 2 X the ULN
  • Albumin > or equal to 3.0
  • Patients may have been treated with anti-EGFR kinase therapy in addition to a platinum based therapy or concurrently with platinum therapy.
  • Informed Consent: Patients must be aware of the investigational nature of the therapy and provide written informed consent.
  • Patients must be able to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, 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 *-HCG) with a sensitivity of at least 50 mIU/L within seven (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 four (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). It is strongly recommended that one of the two reliable forms of contraception be non-hormonal during the entire period of apricoxib tablet treatment and for at least one (1) month after treatment is discontinued. Male patients with female sexual partners who are pregnant, possibly pregnant or who could become pregnant during the study must agree to use condoms during sexual intercourse during the entire period of apricoxib tablet treatment and for at least one (1) month after the last dose of apricoxib.

Exclusion Criteria:

  • Pregnant or breast feeding due to the possible teratogenic effects of this treatment on the fetus.
  • Patients are to be excluded from enrollment for 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 (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771953

Locations
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Martin J Edelman University of Maryland Greenebaum Cancer Center
  More Information

Responsible Party: University of Maryland Greenebaum Cancer Center ( Martin J. Edelman, MD )
Study ID Numbers: H-30405, UMGCC 0822
Study First Received: October 10, 2008
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00771953  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
apricoxib
docetaxel
pemetrexed
Stage IIIb or Stage IV

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009