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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tragara Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Martin Edelman, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT00771953
First received: October 10, 2008
Last updated: May 28, 2013
Last verified: May 2013
  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 progression free survival 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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: From the date of randomization until the first date that recurrent or progressive disease is objectively documented. ] [ Designated as safety issue: Yes ]

Enrollment: 109
Study Start Date: November 2008
Estimated Study Completion Date: July 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Apricoxib 400mg once a day plus Docetaxel 75mg/m2 or Pemetrexed 500mg/m2 every 21 days(Treating physician will determine chemotherapy drug as per his usual practice).
Drug: apricoxib
Oral apricoxib tablets will be provided as white or off-white film-coated tablets available in 100mg strength to be taken every day + docetaxel or pemetrexed administered as an intravenous infusion on the first day of each 21 day cycle.
Placebo Comparator: 2
Placebo once a day plus Docetaxel 75mg/m2 or Pemetrexed 500mg/m2 every 21 days(Treating physician will determine chemotherapy drug as per his usual practice).
Drug: Placebo
Oral placebo tablets will be provided as white or off-white film-coated tablets to be taken every day + docetaxel or pemetrexed administered as an intravenous infusion on the first day of each 21 day cycle.

Detailed Description:

Patients diagnosed with advanced non-small cell lung cancer that has not responded to platinum-based chemotherapy are eligible to particvpate in this study.

Current standard treatments for this type of lung cancer are generally not effective in preventing the cancer from growing. The purpose of this study is to see if adding the drug apricoxib to standard chemotherapy is effective in treting NSCLC. Apricoxib is an investigational drug. Investigational means that it is not approved by the Food and Drug Administration (FDA). Laboratory studies suggest that apricoxib may be useful in the treatment of cancer . This is seen particularly when it is combined with chemotherapy drugs. However, this has not been proven in humans.

Laboratory evidence indicates that apricoxib may benefit patients whose disease over-produces a substance called COX-2. COX-2 can be detected in the urine as a substance called PGE-M (prostaglandin E metabolite). It is thought that patients who have a PGE-M level in the urine that decreases by at least half after taking apricoxib may benefit more than patients whose urine PGE-M decreases by less than half after apricoxib.

This study evaluated whether adding apricoxib to standard chemotherapy treatment will improve outcomes in patients with non-small cell lung cancer whose urine PGE-M decreases at least 50% after taking apricoxib. Apricoxib or placebo was added to either docetaxel or pemetrexed treatment.

  Eligibility

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771953

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Florida
Mercy Research Institute
Miami, Florida, United States, 33133
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Weill Medical Cornell University
New York, New York, United States, 10065
Stony Brook Cancer Center (SUNY)
Stony Brook, New York, United States, 11794
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abramson Cancer Center of Uof Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, West Virginia
West Virginia University Clinical Trials Research Unit
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Martin Edelman, MD
Tragara Pharmaceuticals, Inc.
Investigators
Principal Investigator: Martin J Edelman University of Maryland Greenebaum Cancer Center
  More Information

Publications:

Responsible Party: Martin Edelman, MD, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT00771953     History of Changes
Other Study ID Numbers: HP-00043076, UMGCC 0822
Study First Received: October 10, 2008
Results First Received: May 28, 2013
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 28, 2014