We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer

This study has been terminated.
(protocol violation)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782041
First Posted: October 29, 2008
Last Update Posted: September 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

Primary:

  • To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline.

Secondary:

  • To assess the safety and tolerability of oxaliplatin
  • To assess time to progression and overall survival.

Condition Intervention Phase
Uterine Neoplasms Drug: Oxaliplatin Drug: 5-FluoroUracil Drug: Folinic acid Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin in Combination With 5-fluorouracil (5-FU) and Folinic Acid (FA) in Patients Who Have Failed First-line Treatment for Locally Advanced or Metastatic Cervical Cancer.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response rate [ Time Frame: Throughout the study period ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Throughout the study period ]
  • Overall survival [ Time Frame: Throughout the study period ]
  • Adverse events [ Time Frame: Throughout the study period ]

Enrollment: 11
Study Start Date: January 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1.
Drug: Oxaliplatin
85 mg/m²
Drug: 5-FluoroUracil
2,000 mg/m²
Drug: Folinic acid
20 mg/m²

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have Locally advanced/metastatic squamous or adenocarcinoma of the cervix
  • Prior therapy with cisplatin allowed
  • First-line treatment may have been surgery,radiotherapy or chemotherapy either as a single agent or multi-modality therapy
  • Must have measurable disease
  • Histologically Proven Carcinoma of the cervix
  • ECOG PS ≤2
  • No other serious concomitant illness
  • Fully recovered from any prior therapy
  • Lab: ANC >1500 mm³, Platelets > 100000 mm³, Creatinine ≤ 1.5 x Normal value, Bilirubin ≤ 1.5 x Normal value, SGPT (ALT) ≤ 2.5 x Normal value

Exclusion Criteria:

  • Known allergy to one of the study drugs
  • Peripheral neuropathy > grade2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782041


Locations
Thailand
Sanofi aventis administrative office
Bangkok, Thailand
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Paibulsirijit Sompob, MD Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00782041     History of Changes
Other Study ID Numbers: L_8311
First Submitted: October 28, 2008
First Posted: October 29, 2008
Last Update Posted: September 15, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Oxaliplatin
Fluorouracil
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hematinics