advanced or metastatic cervical cancer MedDRA version: 6.1 Level: PT Classification code 10008342
Conditions
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  Advanced and/or metastatic cervical cancer patients which have failed only a previous platinum-based chemotherapy (with or without concomitant or sequential radiotherapy).   Not amenable to surgery and/or radiotherapy  PS 0-2 (ECOG)  Age> 18 and = 1,500/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin >= 9 g/dL  Hepatic AST and ALT = 45 mL/min  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer  Written Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:  More than 1 previous chemotherapy line  pregnant  Active infection requiring antibiotics  Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of ALIMTA If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (eg, naproxen, piroxicam, diflunisal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of ALIMTA.  Presence (by physical examination) of clinically relevant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study enrollment. (Small effusions noted on CT scan do not exclude the patient from study enrollment)  Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone  Symptomatic peripheral neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective study is to estimate the effectiveness of PEMETREXED in terms of response rate of measurable lesions in a population of recurrent and/or metastatic cervical cancer.;Secondary Objective: Secondary objectives are Progression free Survival (PFS), Overall Survival (OS), the evaluation of toxicity.;Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed