MedDataX Logo

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

NCT ID: NCT00401635

Last Updated: 2007-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

liposomal doxorubicin

Intervention Type DRUG

carboplatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* Present or suspected hemorrhagic syndromes
* Uncooperative and/or unreliable patients
* Patient's inability to access the center
* Refusal of informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute, Naples

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sandro Pignata, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Francesco Perrone, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ospedale Fatebenefratelli, U.O. di Oncologia

Benevento, BN, Italy

Site Status

Ospedale Pierantoni, Divisione di Oncologia Medica

Forlì, FO, Italy

Site Status

Ospedale S. Giovanni Calibita Fatebenefratelli

Roma, Roma, Italy

Site Status

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17486128 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

END-1

Identifier Type: -

Identifier Source: org_study_id