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
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days, as combination therapy to subjects with advanced ovarian or primary peritoneal ca []
- Phase II-To explore the anti-tumor activity of the combination of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days when given to subjects with advanced ovarian or primary peritoneal carcinoma. []
Secondary Outcome Measures
- Phase I-To explore the anti-tumor activity of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma. []
- Phase II-To evaluate the safety profile of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects must understand and voluntarily sign an informed consent document.
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Age > or = to 18 years at the time of signing informed consent form.
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Subjects must be able to adhere to the study visit schedule and other protocol requirements.
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Histological or cytological documentation of advanced ovarian or primary peritoneal carcinoma.
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Radiographic or clinical evidence of measurable metastatic advanced ovarian or primary peritoneal carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
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Subjects must have been treated and progressed following chemotherapy which includes platinum and paclitaxel.
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ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
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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.
Exclusion Criteria:
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Any of the following laboratory abnormalities:
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Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
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Platelet count <100,000 cells/mm3 (100 x 109/L)
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Serum creatinine >2.5 mg/dL (221 mmol/L)
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Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
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Serum total bilirubin >1.2 mg/dL (20 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 > or = to 1 years.
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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 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.
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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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Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
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Prior > or = grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
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Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
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History of cardiac disease, with New York Heart Association Class II or greater (see Appendix V).
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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.)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of California at San Francisco | San Francisco | California | United States | 94115 |
2 | MD Anderson Cancer Center Orlando | Orlando | Florida | United States | 32806 |
3 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
4 | OU Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
5 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Celgene Corporation
- Prologue Research International
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CC-5013-OVRY-001