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Endometrial Cancer - LOHP Alone and With 5FU

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00612495
Enrollment
31
Registered
2008-02-11
Start date
2001-01-31
Completion date
2005-03-31
Last updated
2008-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

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

Interventions

DRUGoxaliplatin, 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.

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Overall RR (World Health Organization [WHO]/Union Internationale Contre le Cancer [International Union Against Cancer] [UICC] criteriaduring the study conduct

Secondary

MeasureTime frame
Progression free-survival, duration of response and overall survival.During the study conduct

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026