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Endometrial CancerPhase 2NCT00401635

END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin

A Phase 2 study testing liposomal doxorubicin and carboplatin in people with Endometrial Cancer, run by National Cancer Institute, Naples at 4 sites in Italy.

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

The purpose of this study is to evaluate activity and toxicity of the combination of carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or recurrent endometrial carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
liposomal doxorubicin and carboplatin
How many people
42 participants
Where
4 sitesItaly
Study dates
Nov 2002to not given
Phase
Phase 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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cytologic / histologic diagnosis of endometrial carcinoma
  • Indication for chemotherapy
  • Age 75 years or less
  • Life expectancy of at least 3 months
  • Measurable disease > 1 cm

Who cannot join

  • Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
  • Performance status (ECOG) > 2
  • Previous chemotherapy treatment
  • Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia)
  • Leukocytes < 4000/mm3, platelets < 100000/mm3
  • Impaired renal function (creatinine > o = 1.25 times the upper normal limit) or liver function (SGOT or SGPT > o = 1.25 times the upper normal limit)
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  • Present or suspected hemorrhagic syndromes
  • Uncooperative and/or unreliable patients
  • Patient's inability to access the center
  • Refusal of informed consent

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Ospedale Fatebenefratelli, U.O. di Oncologia

    Benevento, BN, 82100

  • Ospedale Pierantoni, Divisione di Oncologia Medica

    Forlì, FO, 47100

  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

    Naples, 80131

  • Ospedale S. Giovanni Calibita Fatebenefratelli

    Roma, Roma, 00186

Other trials in Italy

About this study

Official title: Phase II Multicentered Study of First-Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With the Combination of Carboplatin and Liposomal Doxorubicin

The purpose of this study is to evaluate activity and toxicity of the combination of carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or recurrent endometrial carcinoma.

Read the detailed description

Treatment is planned with carboplatin AUC 5 given IV on day 1 and liposomal doxorubicin 40 mg/m2 given IV on day 1, with treatment repeated every 28 days. Delays in treatment administration and dose reductions have been planned according to toxicity.

Being tested
liposomal doxorubicin, carboplatin
Keywords
advanced, recurrent, chemotherapy, first-line
Medical subject headings
Endometrial Neoplasms, Recurrence

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. Objective response rate (complete and partial responses)

  2. Toxicity

Timeline

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

  1. First posted20 Nov 2006 (estimated)
  2. Study startNov 2002

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401635
Sponsor's protocol ID
END-1
Status last verified
Sep 2007
First submitted
17 Nov 2006
Last updated
5 Sep 2007
Results posted
No

Publications

  • Pignata S, Scambia G, Pisano C, Breda E, Di Maio M, Greggi S, Ferrandina G, Lorusso D, Zagonel V, Febbraro A, Riva N, De Rosa V, Gallo C, Perrone F; Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies Group. A multicentre phase II study of carboplatin plus pegylated liposomal doxorubicin as first-line chemotherapy for patients with advanced or recurrent endometrial carcinoma: the END-1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) group. Br J Cancer. 2007 Jun 4;96(11):1639-43. doi: 10.1038/sj.bjc.6603787. Epub 2007 May 8.

    PubMed 17486128

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing liposomal doxorubicin and carboplatin in people with Endometrial Cancer, run by National Cancer Institute, Naples at 4 sites in Italy.

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 5 inclusion and 10 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 5 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. 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 phase mean?

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?

Objective response rate (complete and partial responses). 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 NCT00401635, 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 5 Sep 2007.

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