Patients Who Have Failed First Line Treatment for Locally... | NCT00782041

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

NCT00782041

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Sep 15, 2009Estimated

Enrollment

11Actual

Phase

Phase 2

Conditions

Uterine Neoplasms

Interventions

Oxaliplatin
5-FluoroUracil
Folinic acid

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

protocol violation

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Aug 2003Actual

Completion Date

Not provided

First Submitted Date

Oct 28, 2008

First Submission Date that Met QC Criteria

Oct 28, 2008

First Posted Date

Oct 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2009

Last Update Posted Date

Sep 15, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	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 Drug: 5-FluoroUracil Drug: Folinic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug	85 mg/m²	1
5-FluoroUracil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate		Throughout the study period

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival		Throughout the study period
Overall survival		Throughout the study period
Adverse events

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paibulsirijit Sompob, MD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi aventis administrative office		Bangkok			Thailand

Condition Browse Module

MeSH Terms

ID	Term
D014594	Uterine Neoplasms

Ancestor Terms

ID	Term
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin
D005472	Fluorouracil
D002955	Leucovorin

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D014498	Uracil
D011744	Pyrimidinones

Browse Leaves

Not provided

Browse Branches

Not provided