Endometrial Cancer - LOHP Alone and With 5FU - Tabular View

Tracking Information

First Received Date ^ICMJE

January 28, 2008

Last Updated Date

February 8, 2008

Start Date ^ICMJE

January 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Overall RR (World Health Organization [WHO]/Union Internationale Contre le Cancer [International Union Against Cancer] [UICC] criteria [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00612495 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression free-survival, duration of response and overall survival. [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Endometrial Cancer - LOHP Alone and With 5FU

Official Title ^ICMJE

Parallel Randomised Open Phase II Study of Oxaliplatin (L-OHP) Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Locally Advanced or Metastatic Endometrial Cancer Previously Treated With Cisplatin or Arboplatin

Brief Summary

To determine the efficacy (response rate [RR], time to progression and survival) of oxaliplatin as a single agent and oxaliplatin in combination with 5 FU in patients with advanced/metastatic endometrial cancer pretreated with one prior chemotherapy regimen containing cisplatin (CDDP) or carboplatin and to define the safety profile of each arm of the above mentioned regimens in these patients

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Endometrial Cancer

Intervention ^ICMJE

Drug: oxaliplatin, 5 FU

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients aged at least 18 years, with locally advanced, recurrent or metastatic endometrial adenocarcinoma, histologically diagnosed; at least 1 bidimensionally measurable lesion (> or =to 2 cm on computed tomography [CT]/magnetic resonance imaging [MRI] or > or =to 1 cm clinical lymph node confirmed by ultrasound or > or =to 1 cm skin lesion confirmed by photograph with ruler) located in a non-irradiated area measured less than 2 weeks before inclusion, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
Patients previously treated for locally advanced/metastatic disease with chemo-radiotherapy (total CDDP dose > or =to 100 mg/m2) or chemotherapy containing CDDP or carboplatin with at least 4 weeks' washout period from discontinuation of prior chemotherapy and fully recovered from toxic effects of prior chemotherapy (except for symptomatic peripheral neuropathy < or =to NCI-CTC grade 1 or alopecia).
Patients with clinically or radiologically documented PD or recurrence during or after last chemotherapy and hormone therapy (hormone therapy stopped before study entry), Eastern Cooperative Oncology Group performance status (ECOG PS) < or =to 2, life expectancy > or =to 3 months, adequate bone marrow reserve, normal renal and liver function (neutrophil count > or =to 2000/mm³; platelet count > or =to 100 000/mm³; creatinine levels < or =to 1.5 x the upper limit of normal [ULN] of institutional values or creatinine clearance > 60 mL/min; total bilirubin level < 1.5 x ULN; [alanine amino transferase/aspartate amino-transferase < 2.5 x ULN without liver metastases, < 5 x ULN with liver metastases]).
Laboratory values obtained in the week preceding study entry.
Signed informed consent (prior to all study procedures)

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00612495

Responsible Party

Nathalie Billon/Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

EFC_7496

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Nathalie Billon

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP