Endometrial Cancer - LOHP Alone and With 5FU
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Cancer
Intervention: oxaliplatin, 5 FU (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Nathalie Billon, Study Director, Affiliation: Sanofi-Aventis
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
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Overall RR (World Health Organization [WHO]/Union Internationale Contre le Cancer [International Union Against Cancer] [UICC] criteria
Secondary outcome: Progression free-survival, duration of response and overall survival.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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)
Locations and Contacts
Sanofi-Aventis, Paris, France
Additional Information
clinicalstudyresults.org
Starting date: January 2001
Ending date: March 2005
Last updated: February 8, 2008
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