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A Randomized, Placebo-Controlled Phase II Clinical Trial of Combination Erlotinib (Tarceva) and Celecoxib (Celebrex) Versus Erlotinib (Tarceva)/Placebo in Advanced Non-Small Cell Lung Cancer Patients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

A Randomized, Placebo-Controlled Phase II Clinical Trial of Combination Erlotinib (Tarceva) and Celecoxib (Celebrex) Versus Erlotinib (Tarceva)/Placebo in Advanced Non-Small Cell Lung Cancer Patients


PRIMARY OBJECTIVES:

I. Comparison of progression-free survival (PFS) in patients receiving erlotinib + celecoxib
vs. erlotinib + placebo for advanced NSCLC.

SECONDARY OBJECTIVES:

I. Objective tumor response rate as defined by RECIST Criteria for subjects receiving
erlotinib/celecoxib treatment arms.

II. Categorize the change in e-cadherin expression from baseline to week 8 in a subset of
subjects.

III. Evaluation of overall survival (OS). IV. Measurement of COX-2, EGFR by
immunohistochemistry and EGFR amplification by FISH, and EGFR mutation status to correlate
with clinical response.

V. Measurement of change in urinary PGE-M and correlation with response.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily
on days 1-28.

ARM II: Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice
daily on days 1-28.

In both arms, treatment repeats every 28 days for 12 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


Inclusion

- Pathologically proven NSCLC, stage IIIB (defined as: with pleural effusion or
recurrence after mediastinal radiation and chemotherapy) or IV

- Available tumor tissue for mutation screening

- Measurable stage IIIb or IV disease by RECIST guidelines

- ECOG performance status of 0 or 1

- Progressive disease despite >= 1 prior chemotherapy regimens as standard of care or
subject's refusal or inability to receive standard chemotherapy

- Normal renal function (defined as serum creatinine =< 2mg/dl)

- Normal liver function (defined as serum total bilirubin =< 1.5, and serum
transaminases =< 2.5X the upper limits of normal [ULN]); if liver metastases are
present, serum transaminases > 5X the ULN

- No evidence of coagulopathy (defined as PT and/or PTT =< 1.5X ULN or platelets >=
100,000)

- No evidence of leukopenia (defined as absolute neutrophil count >= 1,500 mm^3)

- Negative pregnancy test prior to initiation of treatment and adequate contraception
throughout treatment

Exclusion

- Cytotoxic chemotherapy agents within 4 weeks of initiating treatment; all toxicities
must be recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of
prior cancer treatment, except alopecia or any clinically insignificant effect, prior
to study initiation

- Evidence of NYHA class III or greater cardiac disease, history of myocardial
infarction, cerebral vascular accident, symptomatic ventricular arrhythmia, or
symptomatic conduction abnormality

- Non-cytoxic therapy within 2 weeks of initiating treatment ; all toxicities must be
recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of prior
cancer treatment, except alopecia or any clinically insignificant effect, prior to
study initiation

- Prior radiotherapy to target lesions is not permitted unless completed more than 4
weeks prior to treatment within the study and that there has been documented
progression at these sites (Radiotherapy to non-target lesions is permitted within 2
weeks of study entry provided all acute effects of the radiotherapy have resolved at
least grade 1)

- Comorbid disease or a medical condition that would impair the ability of the subject
to receive or comply with the study protocol

- Prior malignancy within the last 3 years with the exception of non-melanoma skin
cancer or cervical cancer in situ

- Hypersensitivity of erlotinib or celecoxib or to any of the excipients of these
products

- Hypersensitivity to sulfonamides, aspirin or other NSAIDS

- Prior history of EGFR inhibitor for the treatment of cancer

- Previous history of gastrointestinal ulceration, bleeding or perforation

- Concurrent use of COX-2 inhibitors or other NSAIDS (For subjects on NSAIDS prior to
study initiation, cessation of the drug for 72 hours prior to study entry is
required)

- Chronic or concurrent use of steroids (topical steroids are acceptable if medically
indicated)

- Subjects who require treatment with fluconazole or lithium

- Any evidence of clinically active interstitial lung disease (patients with chronic
stable radiographic changes who are asymptomatic need not be excluded)

- Renal insufficiency (defined as serum creatinine > 2 mg/dl)

- Liver insufficiency (defined as serum total bilirubin > 1.5, or serum transaminases >
2.5C the upper limits of normal [ULN]); if liver metastases are present, serum
transaminases > 5X the ULN

- Coagulopathy (defined as PT and/or PTT > 1.5X ULN or platelets < 100,000)

- Leukopenia (defined as absolute neutrophil count < 1,500/mm^3)

- Pregnancy or inadequate contraception

- Lactating females

- Active CNS metastasis (stable, treated CNS metastasis acceptable)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

1 year post treatment

Safety Issue:

No

Principal Investigator

Karen Reckamp

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

06254

NCT ID:

NCT00499655

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

City of Hope Medical CenterDuarte, California  91010
South Pasadena Cancer CenterSouth Pasadena, California  91030