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Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer

This study has been terminated.
Prologue Research International
Information provided by:
Celgene Identifier:
First received: September 10, 2005
Last updated: November 2, 2005
Last verified: October 2005
Study will deteremine the MTD and evaluate the safety profile of oral lenalidomide on days 1-14 when combined with pemetrexed on day 1 of a 21 days cycle. Subjects will continue on study until documention of disease progression.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: CC-5013
Drug: pemetrexed
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Celgene:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1-14 and pemetrexed on day 1 every 21 days, as combination therapy to subjects with advanced Non-Small Cell Lung Cancer

Secondary Outcome Measures:
  • To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC

Estimated Enrollment: 40
Study Start Date: September 2005
Estimated Study Completion Date: November 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must understand and voluntarily sign an informed consent document.
  2. Age >or= 18 years at the time of signing informed consent form.
  3. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
  4. Histological or cytologic documentation of advanced NSCLC.
  5. Radiographic or clinical evidence of measurable advanced NSCLC. Subjects must have measurable disease at least 2 cm in diameter.
  6. Subjects must have been treated and progressed following chemotherapy.
  7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
  8. 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.

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 cells/mm3 (100 x 109/L)
    3. Serum creatinine >1.5 mg/dL (133 mmol/L)
    4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
    5. Serum total bilirubin >or = 1.5 mg/dL (26 mmol/L)
  2. Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
  3. Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for > 1 year.
  4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
  5. More than one prior chemotherapy for advanced NSCLC.
  6. Concurrent use of any other anti-cancer agents.
  7. Any prior use of lenalidomide.
  8. Pregnant or lactating females.
  9. Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
  10. Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
  11. Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
  12. Known Hepatitis C.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00179699

United States, Florida
MD Anderson - Orlando
Orlando, Florida, United States, 32806
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Norton Healthcare
Louisville, Kentucky, United States, 40202
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
North Shore Hem/Onc Associates
East Setauket, New York, United States, 11733-3456
Sponsors and Collaborators
Celgene Corporation
Prologue Research International
  More Information Identifier: NCT00179699     History of Changes
Other Study ID Numbers: CC-5013-NSCL-002
Study First Received: September 10, 2005
Last Updated: November 2, 2005

Keywords provided by Celgene:
Non Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 25, 2017