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

Primary Purpose

Uterine Neoplasms

Status
Terminated
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Oxaliplatin
5-FluoroUracil
Folinic acid
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi aventis administrative office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Progression-free survival
Overall survival
Adverse events

Full Information

First Posted
October 28, 2008
Last Updated
September 14, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00782041
Brief Title
Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Why Stopped
protocol violation
Study Start Date
January 2003 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
85 mg/m²
Intervention Type
Drug
Intervention Name(s)
5-FluoroUracil
Intervention Description
2,000 mg/m²
Intervention Type
Drug
Intervention Name(s)
Folinic acid
Intervention Description
20 mg/m²
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Throughout the study period
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Throughout the study period
Title
Overall survival
Time Frame
Throughout the study period
Title
Adverse events
Time Frame
Throughout the study period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paibulsirijit Sompob, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi aventis administrative office
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

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

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