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
- 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)