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A Study to Evaluate the Single-Agent Lenalidomide in Subjects With Recurrent Non-Small-Cell Lung Cancer
This study has been completed.
Sponsors and Collaborators: Celgene Corporation
Prologue Research International
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00179686
  Purpose

Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. Subjects will continue until disease progression is documented.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: CC-5013
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid, CC-5013) in Subjects With Recurrent Non-Small Cell Lung Cancer

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • To determine the activity of lenalidiomide in recurrent non-small cell lung cancer. Activity will be assessed by measuring the response rate, tumor control rate, and time to tumor progression.

Secondary Outcome Measures:
  • To evaluate the safety of lenalidomide monotherapy as treatment for subjects with recurrent non-small cell lung cancer.

Estimated Enrollment: 40
Study Start Date: March 2005
Estimated Study Completion Date: July 2006
  Eligibility

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

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age >or = to 18 years at the time of signing the informed consent form
  3. Able to adhere to the study visit schedule and other protocol requirements
  4. Must have a histologically confirmed diagnosis of non small cell lung cancer that has recurred following at least two prior regimens. Those regimens must have contained both a platinum compound and a taxane either sequentially or in combination
  5. Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter.
  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix II).
  7. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug.

Exclusion Criteria:

  1. Any of the following laboratory abnormalities:

    1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
    2. Platelet count <100,000/mm3 (100 x 109/L)
    3. Serum creatinine >2.5 mg/dL (221 mmol/L)
    4. Serum SGOT/AST or SGPT/ALT >5.0 x upper limit of normal (ULN)
    5. Serum total bilirubin >2.0 mg/dL (34 mmol/L)
  2. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  3. Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or = to 1 year.
  4. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  5. Pregnant or lactating females.
  6. Prior > or = grade 3 allergic reaction/hypersensitivity to thalidomide.
  7. Prior > or = grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
  8. Prior use of lenalidomide.
  9. Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179686

Locations
United States, Alabama
Birmingham Cancer Center
Birmingham, Alabama, United States, 35294
United States, Illinois
Rush Cancer Institute
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Cancer and Blood Institute
Metairie, Louisiana, United States, 70006
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Celgene Corporation
Prologue Research International
  More Information

Study ID Numbers: CC-5013-NSCL-001
Study First Received: September 10, 2005
Last Updated: December 19, 2006
ClinicalTrials.gov Identifier: NCT00179686  
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
celgene
cc-5013
NSCLC
CC5013
Revlimid
Non-Small Cell Lung Cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Lenalidomide
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009