Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
1. Subjects must understand and voluntarily sign an informed consent document.
2. Age >or = to 18 years at the time of signing informed consent form.
3. Subjects must be able to adhere to the study visit schedule and other protocol
4. Histological or cytological documentation of advanced ovarian or primary peritoneal
5. Radiographic or clinical evidence of measurable metastatic advanced ovarian or
primary peritoneal carcinoma. Subjects must have measurable disease at least 2 cm in
6. Subjects must have been treated and progressed following chemotherapy which includes
platinum and paclitaxel.
7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
1. Any of the following laboratory abnormalities:
1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
2. Platelet count <100,000 cells/mm3 (100 x 109/L)
3. Serum creatinine >1.5 mg/dL (133 mmol/L)
4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
5. Serum total bilirubin >2.0 mg/dL (34 mmol/L)
2. 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.
3. 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
4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in
case of clinical suspicion of central nervous system involvement).
5. 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
6. Concurrent use of any other anti-cancer agents.
7. Any prior use of lenalidomide.
8. Prior > or = to grade 3 (see Appendix III) rash or any desquamating (blistering) rash
while taking thalidomide.
9. Prior . Or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to
10. Use of any standard or experimental anti-cancer drug therapy within 28 days of the
initiation of study drug therapy.
11. Known active Hepatitis C.