NCT00179725
Terminated
Phase 1
Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
ConditionsOvarian Cancer
Overview
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Celgene Corporation
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- 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
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •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
- •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 \>2.5 mg/dL (221 mmol/L)
- •Serum SGOT/AST or SGPT/ALT \>3.0 x upper limit of normal (ULN)
- •Serum total bilirubin \>1.2 mg/dL (20 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 \> or = to 1 years.
- •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.
Outcomes
Primary Outcomes
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 Outcomes
- 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
Investigators
Study Sites (5)
Loading locations...
Similar Trials
Completed
Phase 1
Study of Lenalidomide With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal CarcinomaOvarian CancerNCT00179712Celgene Corporation60
Terminated
Phase 1
Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT00179699Celgene Corporation40
Terminated
Phase 1
A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the PancreasPancreatic CancerNCT00179751Celgene Corporation50
Completed
Phase 1
Study of Lenalidomide and Docetaxel in Subjects With Androgen Independent Prostate CancerProstate CancerNCT01378091Columbia University64
Completed
Phase 1
Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or MetastaticTumorsNCT00127829AstraZeneca66