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Ovarian CancerPhase 1/2NCT00179712

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

A Phase 1/2 study testing CC-5013 and topotecan in people with Ovarian Cancer, run by Celgene Corporation at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
CC-5013 and topotecan
How many people
60 participants
Where
3 sitesUnited States
Study dates
Apr 2005to Nov 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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)
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  • 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.
  • Known active Hepatitis C.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Medical College of GeorgiaDept of OBGYN

    Augusta, Georgia, 30912-3335

  • Ohio State University

    Columbus, Ohio, 43210

  • University of MinnesotaObstetrics & Gynecology, MMC

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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

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
Being tested
CC-5013, topotecan
Keywords
cc-5013, revlimid, ovarian cancer, celgene
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I-To determine the MTD and evaluate the safety profile of oral lenalidomide and topotecan

  2. 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)

  1. Phase I-To explore the anti-tumor activity based on response of the combination of lenalidomide and topotecan.

  2. Phase II-To explore the safety profile of the combination of lenalidomide and topotecan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00179712
Sponsor's protocol ID
CC-5013-OVRY-002
Status last verified
Nov 2016
First submitted
10 Sep 2005
Last updated
1 Dec 2016
Results posted
No

Publications

  • 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.

    PubMed 21556801

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CC-5013 and topotecan in people with Ovarian Cancer, run by Celgene Corporation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I-To determine the MTD and evaluate the safety profile of oral lenalidomide and topotecan. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00179712, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.

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