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 - Full Text View

Sponsors and Collaborators:	Celgene Corporation Prologue Research International
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00179699

Purpose

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 I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed disodium Pemetrexed Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety Study
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

Further study details as provided by Celgene Corporation:

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

Eligibility

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

Criteria

Inclusion Criteria:

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

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)
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.
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.
Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
More than one prior chemotherapy for advanced NSCLC.
Concurrent use of any other anti-cancer agents.
Any prior use of lenalidomide.
Pregnant or lactating females.
Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
Known Hepatitis C.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179699

Locations

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

Study ID Numbers:	CC-5013-NSCL-002
Study First Received:	September 10, 2005
Last Updated:	November 2, 2005
ClinicalTrials.gov Identifier:	NCT00179699
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

cc-5013
Non Small Cell Lung Cancer
revlimid
celgene
cc5013

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Lenalidomide
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009