Status:
COMPLETED
Study of Lenalidomide With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
Lead Sponsor:
Celgene Corporation
Collaborating Sponsors:
Prologue Research International
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 est...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00179712
Start Date
April 1 2005
End Date
November 1 2006
Last Update
December 1 2016
Active Locations (3)
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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