PHASE II STUDY ON PEMETREXED IN ADVANCED AND/OR RECURRENT CERVICAL CANCER - ND

Conditions: advanced or metastatic cervical cancer
MedDRA version: 6.1Level: PTClassification code 10008342

Registration Number: EUCTR2006-005626-24-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

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 < 75 years

 Life expectancy of at least 3 months

 Adequate organ functions

 Hematopoietic

Absolute neutrophil count >= 1,500/mm^3

Platelet count >= 100,000/mm^3

Hemoglobin >= 9 g/dL

 Hepatic

AST and ALT <= 3 times upper limit of normal (ULN)*

Alkaline phosphatase <= 3 times ULN*

Bilirubin <= 1.5 times ULN NOTE: * <= 5 times ULN if liver metastases are present

 Renal

Creatinine clearance >= 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

 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures