Endometrial Cancer - LOHP Alone and With 5FU

NCT00612495 | Completed Phase 2

• 1 other identifier: EFC_7496
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Overall RR (World Health Organization [WHO]/Union Internationale Contre le Cancer [International Union Against Cancer] [UICC] criteria

  during the study conduct

Secondary Outcomes (1)

• Progression free-survival, duration of response and overall survival.

  During the study conduct

Interventions

oxaliplatin, 5 FU DRUG

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.

Also known as: Eloxatin, Fluorouracil

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nathalie Billon

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 11, 2008
• Study Start: January 1, 2001
• Study Completion: March 1, 2005
• Last Updated: February 11, 2008

Record last verified: 2008-01

Locations

FR (1)