Brief Title
Endometrial Cancer - LOHP Alone and With 5FU
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
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
Study Phase
Phase 2
Study Type
Interventional
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.
Condition
Endometrial Cancer
Intervention
oxaliplatin, 5 FU
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
Drug
Estimated Enrollment
31
Start Date
January 2001
Completion Date
March 2005
Eligibility 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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nathalie Billon, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00612495
Organization ID
EFC_7496
Study Sponsor
Sanofi
Study Sponsor
Nathalie Billon, Study Director, Sanofi
Verification Date
January 2008