Study of Lenalidomide With Topotecan 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 1-14 when given with topotecan on days 1-5 of every 21 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-14 with topotecan on days 1-5 in 21 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 MTD and evaluate the safety profile of oral lenalidomide and topotecan []
- Phase II-To explore the anti-tumor activity based on objective response rate (CR + PR) of the combination of oral lenalidomide and topotecan []
Secondary Outcome Measures
- Phase I-To explore the anti-tumor activity based on response of the combination of lenalidomide and topotecan. []
- Phase II-To explore the safety profile of the combination of lenalidomide and topotecan []
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).
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 >1.5 mg/dL (133 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 >2.0 mg/dL (34 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 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) rash or any desquamating (blistering) rash while taking thalidomide.
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Prior . Or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to 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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Known active Hepatitis C.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Medical College of GeorgiaDept of OBGYN | Augusta | Georgia | United States | 30912-3335 |
2 | University of MinnesotaObstetrics & Gynecology, MMC | Minneapolis | Minnesota | United States | 55455 |
3 | Ohio State University | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Celgene Corporation
- Prologue Research International
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- CC-5013-OVRY-002