ILX651-231: Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00078455

Purpose

This is a Phase II, non-randomized, open label study of ILX651 in patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate. The secondary objectives are to determine the progression free survival, duration of response, time to tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic profile.

Condition	Intervention	Phase
Non-Small-Cell Lung Carcinoma	Drug: ILX651	Phase II

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title: A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

Further Study Details:

Study start: December 2003
Study Completion: June 2006

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Histologically confirmed locally advanced or metastatic NSCLC previously treated with 2 prior chemotherapy regimens (not including prior adjuvant therapy for stage I or II disease).

Disease recurrence or progression after prior therapy with a platinum-based and a taxane-based regimen, given either concurrently or separately.

Measurable disease. Measurable lesions should be outside the field of radiation. Where measurable lesions are within a previously irradiated field, there must be objective evidence of progression of the lesion prior to patient enrollment.

Male or female patients greater than or equal to 18 years of age.

ECOG performance status of 0 or 1.

Must have adequate organ and immune system function as indicated by the following laboratory values, obtained less than or equal to 2 weeks prior to registration:

Absolute neutrophil count (ANC) greater than or equal to 1.5 x 1,000,000,000

Hemoglobin greater than or equal to 9.0 g/dL

Platelet count greater than or equal to 100 x 1,000,000,000/L

Serum creatinine or calculated creatinine clearance less than or equal to 1.5 mg/dL or greater than or equal to 60 mL/min

Serum total bilirubin within limits of normal values

AST and ALT less than or equal to 2 times the upper limit of normal (ULN)

Alkaline phosphatase within limits of normal values

Anti-cancer therapy, major surgery, or irradiation must have been completed at least 3 weeks before enrollment in this study. Patient must have recovered from the acute side effects incurred as a result of previous therapy.

Female patients with childbearing potential must have a negative pregnancy test within 7 days of study enrollment. Men and women of reproductive potential must use an effective contraceptive method while enrolled in the study.

Signed informed consent (includes HIPAA authorization).

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study admission:

Patients with uncontrolled congestive heart failure or angina, patients with a history of myocardial infarction within 2 months of enrollment, or patients with cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification.

Previously treated with > 2 prior chemotherapy regimens for advanced or metastatic disease.

Prior radiotherapy to the only site of measurable disease.

Known hypersensitivity to study drug or its analogs.

Use of investigational agents within previous 30 days.

Known, active infection, or known HIV positive or presence of an AIDS related illness.

Active secondary malignancy except minor skin cancers.

Presence of symptomatic active brain metastases, including leptomeningeal involvement.

Any significant concurrent disease or illness, or psychiatric disorders or alcohol or chemical abuse that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results.

Pregnant or lactating females.

Location Information

Arizona
US Oncology/ Arizona Clinical Research Center, Tucson, Arizona, 85712, United States

California
Cancer Institute Medical Group, Santa Monica, California, 90404, United States

Colorado
Anshutz Cancer Pavillion, Aurora, Colorado, 80010, United States

Florida
US Oncology / Ocala Oncology, Ocala, Florida, 34474, United States

Indiana
US Oncology / Central Indiana Cancer Centers, Indianapolis, Indiana, 46227, United States

Louisiana
Hematology and Oncology Specialists, New Orleans, Louisiana, 70115, United States

Tennessee
Sarah Cannon Cancer Center, Nashville, Tennessee, 37203, United States

Texas
US Oncology / Texas Cancer Center, Dallas, Texas, 75230, United States
Joe Arrington Cancer Center, Lubbock, Texas, 79410, United States
US Oncology / Tyler Cancer Center, Tyler, Texas, 75702, United States

More Information

Study ID Numbers: ILX651-231
ClinicalTrials.gov Identifier: NCT00078455
Health Authority: United States: Food and Drug Administration