Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma

Stopped early · Phase 1/Phase 2

Conditions studied: Ovarian Cancer

In brief

Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-21 with liposomal doxorubicinon day 1 in 28 day cycles until disease progression is documented.

Key facts

Study ID

NCT00179725

Run by

Celgene Corporation

People needed

60

Starts

2005-11-01

Expected to finish

2007-06-01

Last updated by the study team

2006-04-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must understand and voluntarily sign an informed consent document.
• Age > or = to 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 cytological documentation of advanced ovarian or primary peritoneal carcinoma.
• Radiographic or clinical evidence of measurable metastatic advanced ovarian or primary peritoneal carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
• Subjects must have been treated and progressed following chemotherapy which includes platinum and paclitaxel.
• ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
• Must have 2-d Echocardiogram/MUGA indicating a LVEF above the institutional lower limit of normal within 42 days prior to first dose of study drug.

You may not qualify if…

• 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 >2.5 mg/dL (221 mmol/L)
• Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
• Serum total bilirubin >1.2 mg/dL (20 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 > or = to 1 years.
• 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 1 prior chemotherapy regimen. However, subjects with platinum sensitive disease (i.e., subjects who fail a platinum containing regimen at least six months after completing the regimen) who are retreated with a platinum containing regimen are eligible.
• Concurrent use of any other anti-cancer agents.
• Any prior use of Lenalidomide.
• Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
• Prior > or = grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
• Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
• History of cardiac disease, with New York Heart Association Class II or greater (see Appendix V).
• Subjects who have received > 200mg/m2 of anthracycline or anthracendione either alone or in combination. (Additional caution must be taken in subjects with mediastinal radiation.)

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• MD Anderson Cancer Center Orlando — Orlando, Florida, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• OU Health Sciences Center — Oklahoma City, Oklahoma, United States
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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