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

Sanofi

Status and phase: Terminated; Phase 2

Conditions: Uterine Neoplasms

Treatments: Drug: Oxaliplatin; Drug: Folinic acid; Drug: 5-FluoroUracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782041

L_8311

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

1

Experimental group

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.

Treatment:

Drug: 5-FluoroUracil

Drug: Folinic acid

Drug: Oxaliplatin