Endometrial Cancer - LOHP Alone and With 5FU
This study has been completed.
Information provided by:
First received: January 28, 2008
Last updated: February 8, 2008
Last verified: January 2008
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
Drug: oxaliplatin, 5 FU
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Progression free-survival, duration of response and overall survival. [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
Drug: oxaliplatin, 5 FU
Oxaliplatin:130 mg/m² as a 2-hour intravenous (IV) infusion in 500 mL of 5% glucose solution on Day 1 and repeated every 3 weeks.
5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 to Day 4, repeated every 3 weeks.
Other Name: Eloxatin, Fluorouracil
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00612495
|Paris, France |
||Nathalie Billon/Study Director, sanofi-aventis
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 28, 2008
||February 8, 2008
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 25, 2016
Genital Neoplasms, Female
Neoplasms by Site
Genital Diseases, Female
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs