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Endometrial Cancer - LOHP Alone and With 5FU
This study has been completed.
First Received: January 28, 2008   Last Updated: February 8, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00612495
  Purpose

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


Condition Intervention Phase
Endometrial Cancer
Drug: oxaliplatin, 5 FU
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Fluorouracil Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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 ]

Enrollment: 31
Study Start Date: January 2001
Study Completion Date: March 2005
Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612495

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Nathalie Billon Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Responsible Party: sanofi-aventis ( Nathalie Billon/Study Director )
Study ID Numbers: EFC_7496
Study First Received: January 28, 2008
Last Updated: February 8, 2008
ClinicalTrials.gov Identifier: NCT00612495     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Antimetabolites
Immunologic Factors
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Endometrial Cancer
Immunosuppressive Agents
Genital Diseases, Female
Endometrial Neoplasms
Oxaliplatin
Cisplatin
Fluorouracil
Uterine Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Immunosuppressive Agents
Pharmacologic Actions
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms
Oxaliplatin
Neoplasms by Site
Therapeutic Uses
Fluorouracil
Uterine Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009