Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00612495 |
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 |
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 |
Enrollment: | 31 |
Study Start Date: | January 2001 |
Study Completion Date: | March 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 |
Antimetabolites Immunologic Factors Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Endometrial Cancer Immunosuppressive Agents |
Genital Diseases, Female Endometrial Neoplasms Oxaliplatin Cisplatin Fluorouracil Uterine Neoplasms |
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 |