Study of Lenalidomide With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma

Completed · 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 1-14 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.

Key facts

Study ID

NCT00179712

Run by

Celgene Corporation

People needed

60

Starts

2005-04-01

Expected to finish

2006-11-01

Last updated by the study team

2016-12-01

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).

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 >1.5 mg/dL (133 mmol/L)
• Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
• Serum total bilirubin >2.0 mg/dL (34 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 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) rash or any desquamating (blistering) rash while taking thalidomide.
• Prior . Or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
• Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
• Known active Hepatitis C.

Where it is running

• Medical College of GeorgiaDept of OBGYN — Augusta, Georgia, United States
• University of MinnesotaObstetrics & Gynecology, MMC — Minneapolis, Minnesota, United States
• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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