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

Sponsor

Celgene Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT00179699

Collaborator

Prologue Research International (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer	Drug: CC-5013 Drug: pemetrexed	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2005

Study Completion Date :

Nov 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:
Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
Platelet count <100,000 cells/mm3 (100 x 109/L)
Serum creatinine >1.5 mg/dL (133 mmol/L)
Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
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

Locations

	Site	City	State	Country	Postal Code
1	MD Anderson - Orlando	Orlando	Florida	United States	32806
2	University of Iowa	Iowa City	Iowa	United States	52242
3	Norton Healthcare	Louisville	Kentucky	United States	40202
4	Washington University	St. Louis	Missouri	United States	63110
5	North Shore Hem/Onc Associates	East Setauket	New York	United States	11733-3456