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Study of ILX651 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00078455
First received: February 25, 2004
Last updated: June 19, 2008
Last verified: November 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Study Start Date: December 2003
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: A. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 1,000,000,000. B. Hemoglobin greater than or equal to 9.0 g/dL. C. Platelet count greater than or equal to 100 x 1,000,000,000/L. D. Serum creatinine or calculated creatinine clearance less than or equal to 1.5 mg/dL or greater than or equal to 60 mL/min. E. Serum total bilirubin within limits of normal values. F. AST and ALT less than or equal to 2 times the upper limit of normal (ULN). G. 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 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.
  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: NCT00078455

Locations
United States, Arizona
US Oncology/ Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, California
Cancer Institute Medical Group
Santa Monica, California, United States, 90404
United States, Colorado
Anshutz Cancer Pavillion
Aurora, Colorado, United States, 80010
United States, Florida
US Oncology / Ocala Oncology
Ocala, Florida, United States, 34474
United States, Indiana
US Oncology / Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
United States, Louisiana
Hematology and Oncology Specialists
New Orleans, Louisiana, United States, 70115
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
US Oncology / Texas Cancer Center
Dallas, Texas, United States, 75230
Joe Arrington Cancer Center
Lubbock, Texas, United States, 79410
US Oncology / Tyler Cancer Center
Tyler, Texas, United States, 75702
Sponsors and Collaborators
Genzyme, a Sanofi Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00078455     History of Changes
Other Study ID Numbers: ILX651-231
Study First Received: February 25, 2004
Last Updated: June 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
NSCLC
Non-small Cell Lung Cancer
Non-small Cell Lung Carcinoma
Locally Advanced NSCLC
Metastatic NSCLC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014