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

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.

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: CC-5013; Drug: pemetrexed

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • MD Anderson - Orlando
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • East Setauket, New York, United States, 11733-3456
      • North Shore Hem/Onc Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

• Sponsor: Celgene Corporation
• Collaborators: Prologue Research International

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Study Completion: November 1, 2006

Study Registration Dates

• First Submitted: September 10, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): November 7, 2005
• Last Update Submitted That Met QC Criteria: November 2, 2005
• Last Verified: October 1, 2005

More Information

Terms related to this study

• Keywords: Non Small Cell Lung Cancer; celgene; revlimid; cc-5013; cc5013
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Folic Acid Antagonists; Lenalidomide; Pemetrexed
• Other Study ID Numbers: CC-5013-NSCL-002