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
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT00179699
- Lead Sponsor
- Celgene Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
- 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.
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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)
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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.
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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.
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Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
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More than one prior chemotherapy for advanced NSCLC.
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Concurrent use of any other anti-cancer agents.
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Any prior use of lenalidomide.
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Pregnant or lactating females.
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Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
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Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
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Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
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Known Hepatitis C.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method 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
Name Time Method To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC
Trial Locations
- Locations (5)
MD Anderson - Orlando
🇺🇸Orlando, Florida, United States
Washington University
🇺🇸St. Louis, Missouri, United States
North Shore Hem/Onc Associates
🇺🇸East Setauket, New York, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States