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

NCT00179712 | Completed Phase 1

• 1 other identifier: CC-5013-OVRY-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

cc-5013; revlimid; ovarian cancer; celgene

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Interventions

CC-5013 DRUG

topotecan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 \>1.5 mg/dL (133 mmol/L)
• Serum SGOT/AST or SGPT/ALT \>3.0 x upper limit of normal (ULN)
• Serum total bilirubin \>2.0 mg/dL (34 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 \> 1 year.
• 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) rash or any desquamating (blistering) rash while taking thalidomide.
• Prior . Or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
• Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.

Sponsors & Collaborators

• Celgene Corporation: lead
• Prologue Research International: collaborator

Study Sites (3)

Medical College of GeorgiaDept of OBGYN

Augusta, Georgia, 30912-3335, United States

Location

University of MinnesotaObstetrics & Gynecology, MMC

Minneapolis, Minnesota, 55455, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 21556801 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Lenalidomide; Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2005
• Study Completion: November 1, 2006
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

US (3)