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

This study has been completed.
Sponsor:
Collaborator:
Prologue Research International
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00179712
First received: September 10, 2005
Last updated: December 19, 2006
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: CC-5013
Drug: topotecan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
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 Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 60
Study Start Date: April 2005
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179712

Locations
United States, Georgia
Medical College of GeorgiaDept of OBGYN
Augusta, Georgia, United States, 30912-3335
United States, Minnesota
University of MinnesotaObstetrics & Gynecology, MMC
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Celgene Corporation
Prologue Research International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179712     History of Changes
Other Study ID Numbers: CC-5013-OVRY-002
Study First Received: September 10, 2005
Last Updated: December 19, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
cc-5013
revlimid
ovarian cancer
celgene

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Topotecan
Lenalidomide
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014