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

November 30, 2016 updated by: Celgene Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912-3335
        • Medical College of GeorgiaDept of OBGYN
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of MinnesotaObstetrics & Gynecology, MMC
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Phase I-To determine the MTD and evaluate the safety profile of oral lenalidomide and topotecan
Phase II-To explore the anti-tumor activity based on objective response rate (CR + PR) of the combination of oral lenalidomide and topotecan

Secondary Outcome Measures

Outcome Measure
Phase I-To explore the anti-tumor activity based on response of the combination of lenalidomide and topotecan.
Phase II-To explore the safety profile of the combination of lenalidomide and topotecan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Collaborators

Prologue Research International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-OVRY-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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