Back to resultsEndometrial Cancer - LOHP Alone and With 5FU
Primary Purpose
Endometrial Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
oxaliplatin, 5 FU
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer
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)
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Overall RR (World Health Organization [WHO]/Union Internationale Contre le Cancer [International Union Against Cancer] [UICC] criteria
Secondary Outcome Measures
Progression free-survival, duration of response and overall survival.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00612495
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
oxaliplatin, 5 FU
Other Intervention Name(s)
Eloxatin, Fluorouracil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall RR (World Health Organization [WHO]/Union Internationale Contre le Cancer [International Union Against Cancer] [UICC] criteria
Time Frame
during the study conduct
Secondary Outcome Measure Information:
Title
Progression free-survival, duration of response and overall survival.
Time Frame
During the study conduct
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Billon
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Paris
Country
France
12. IPD Sharing Statement
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Endometrial Cancer - LOHP Alone and With 5FU
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