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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

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CC-5013
liposomal doxorubicin
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring cc-5013, revlimid, ovarian cancer, celgene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. Concurrent use of any other anti-cancer agents. Any prior use of Lenalidomide. Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide. Prior > or = grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy. History of cardiac disease, with New York Heart Association Class II or greater (see Appendix V). 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.)

Sites / Locations

  • University of California at San Francisco
  • MD Anderson Cancer Center Orlando
  • Memorial Sloan-Kettering Cancer Center
  • OU Health Sciences Center
  • Swedish Cancer Institute

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
September 10, 2005
Last Updated
April 10, 2006
Sponsor
Celgene Corporation
Collaborators
Prologue Research International
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1. Study Identification

Unique Protocol Identification Number
NCT00179725
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Terminated
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Celgene Corporation
Collaborators
Prologue Research International

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
cc-5013, revlimid, ovarian cancer, celgene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CC-5013
Intervention Type
Drug
Intervention Name(s)
liposomal doxorubicin
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
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.
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Concurrent use of any other anti-cancer agents. Any prior use of Lenalidomide. Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide. Prior > or = grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy. History of cardiac disease, with New York Heart Association Class II or greater (see Appendix V). 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.)
Facility Information:
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
MD Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
OU Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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