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Study of Lenalidomide With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma

NCT ID: NCT00179712

Last Updated: 2016-12-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-11-30

Brief Summary

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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 established, additional subjects will be enrolled and receive oral lenalidomide on days 1-14 with topotecan on days 1-5 in 21 day cycles until disease progression is documented.

Detailed Description

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Conditions

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Ovarian Cancer

Keywords

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cc-5013 revlimid ovarian cancer celgene

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Interventions

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CC-5013

Intervention Type DRUG

topotecan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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 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).

Exclusion Criteria

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 year.
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) rash or any desquamating (blistering) rash while taking thalidomide.
9. Prior . Or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Prologue Research International

INDUSTRY

Sponsor Role collaborator

Celgene Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical College of GeorgiaDept of OBGYN

Augusta, Georgia, United States

Site Status

University of MinnesotaObstetrics & Gynecology, MMC

Minneapolis, Minnesota, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Carter JS, Downs LS Jr. A prospective clinical trial of lenalidomide with topotecan in women with advanced epithelial ovarian carcinoma. Int J Clin Oncol. 2011 Dec;16(6):666-70. doi: 10.1007/s10147-011-0243-1. Epub 2011 May 10.

Reference Type BACKGROUND
PMID: 21556801 (View on PubMed)

Other Identifiers

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CC-5013-OVRY-002

Identifier Type: -

Identifier Source: org_study_id