Status:
COMPLETED
Endometrial Cancer - LOHP Alone and With 5FU
Lead Sponsor:
Sanofi
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 endome...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00612495
Start Date
January 1 2001
End Date
March 1 2005
Last Update
February 11 2008
Active Locations (1)
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1
Sanofi-Aventis
Paris, France