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

NCT00782041 | Terminated Phase 2

• 1 other identifier: L_8311
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Neoplasms

Outcome Measures

Primary Outcomes (1)

• Response rate

  Throughout the study period

Secondary Outcomes (3)

• Progression-free survival

  Throughout the study period

• Overall survival

  Throughout the study period

• Adverse events

  Throughout the study period

Study Arms (1)

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

Oxaliplatin DRUG

85 mg/m²

1

5-FluoroUracil DRUG

2,000 mg/m²

1

Folinic acid DRUG

20 mg/m²

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi aventis administrative office

Bangkok, Thailand

Location

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Paibulsirijit Sompob, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: January 1, 2003
• Primary Completion: August 1, 2003
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

TH (1)