Status:
TERMINATED
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
Lead Sponsor:
Celgene Corporation
Collaborating Sponsors:
Prologue Research International
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 documen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00179699
Start Date
September 1 2005
End Date
November 1 2006
Last Update
November 7 2005
Active Locations (5)
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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