Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
NCT ID: NCT00179725
Last Updated: 2006-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2005-11-30
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Interventions
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CC-5013
liposomal doxorubicin
Eligibility Criteria
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Inclusion Criteria
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 requirements.
4. Histological or cytological documentation of advanced ovarian or primary peritoneal carcinoma.
5. Radiographic or clinical evidence of measurable metastatic advanced ovarian or primary peritoneal carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
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).
8. 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
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 \>2.5 mg/dL (221 mmol/L)
4. Serum SGOT/AST or SGPT/ALT \>3.0 x upper limit of normal (ULN)
5. Serum total bilirubin \>1.2 mg/dL (20 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 \> or = to 1 years.
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 are eligible.
6. Concurrent use of any other anti-cancer agents.
7. Any prior use of Lenalidomide.
8. Prior \> or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
9. Prior \> or = grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
10. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
11. History of cardiac disease, with New York Heart Association Class II or greater (see Appendix V).
12. Subjects who have received \> 200mg/m2 of anthracycline or anthracendione either alone or in combination. (Additional caution must be taken in subjects with mediastinal radiation.)
18 Years
FEMALE
No
Sponsors
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Prologue Research International
INDUSTRY
Celgene Corporation
INDUSTRY
Locations
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University of California at San Francisco
San Francisco, California, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
OU Health Sciences Center
Oklahoma City, Oklahoma, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Other Identifiers
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CC-5013-OVRY-001
Identifier Type: -
Identifier Source: org_study_id