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

This study has been terminated.
(protocol violation)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00782041
First received: October 28, 2008
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response rate [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782041

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

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00782041     History of Changes
Other Study ID Numbers: L_8311
Study First Received: October 28, 2008
Last Updated: September 14, 2009
Health Authority: Thailand: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013