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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Non Small Cell Lung Cancer

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Trial Information

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


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

- 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).

- Alanine aminotransferase (SGOT) and aspartate aminotransferase (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

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to disease progression (TTP)

Outcome Time Frame:

At the time of clinical progression

Safety Issue:

Yes

Principal Investigator

Martin J Edelman

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

HP-00043076

NCT ID:

NCT00771953

Start Date:

January 2009

Completion Date:

December 2012

Related Keywords:

  • Lung Cancer
  • Non Small Cell Lung Cancer
  • apricoxib
  • docetaxel
  • pemetrexed
  • Stage IIIb or Stage IV
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Rush University Medical CenterChicago, Illinois  60612-3824
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of MiamiMiami, Florida  33136
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Mercy Research InstituteMiami, Florida  33133
Weill Medical Cornell UniversityNew York, New York  10065
Stony Brook Cancer Center (SUNY)Stony Brook, New York  11794
Abramson Cancer Center of Uof PennsylvaniaPhiladelphia, Pennsylvania  19104
West Virginia University Clinical Trials Research UnitMorgantown, West Virginia  26506