Endometrial Cancer – LOHP Alone and With 5FU

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

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

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Endometrial Cancer

Intervention

oxaliplatin, 5 FU

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

January 2001

Completion Date

March 2005

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)

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nathalie Billon, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT00612495

Organization ID

EFC_7496

Study Sponsor

Sanofi

Study Sponsor

Nathalie Billon, Study Director, Sanofi

Verification Date

January 2008