malignant pleural mesothelioma, non small cell lung cancer, pancreatic cancer and breast cancer MedDRA version: 9.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ALIMTA*1FL POLV 500MG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
ISTITUTO ONCOLOGICO ROMAGNOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients must have histologically or cytologically confirmed of MPM, NSCLC, Metastatic Breast cancer, Pancreatic cancer in advanced stage, not surgically treatable and /or relapsed after conventional chemotherapy. 2.Patients may have preferably evaluable or measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease. Patients with evaluable disease may be enrolled in this dose-finding study provided that they are evaluable for toxicity. 3.Patients may be pretreated with chemo and/or previous radiotherapy. At least 1 month has to be passed from the end of previous treatment 4.Age >18 years. 5.Life expectancy of greater than 3 months . 6.ECOG performance status 3,000/mL -absolute neutrophil count >1,500/mL -platelets >100,000/mL -total bilirubin within normal institutional limits -AST(SGOT)/ALT(SGPT)60 mL/min 8.The effects of Alimta on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because Alimta is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 9.Ability to understand and the willingness to sign a written informed consent document. 10.Negative pregnancy test with 7 days from study entry. 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: 1.Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 2.Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Alimta or other agents used in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is to verify the safety ( determined by clinical toxicities and measured by MTD and DLT) and feasibility of continuous (12 hours) intravenous infusion of Alimta.;Secondary Objective: Secondary objectives are the study of pharmacokinetic parameters and to verify the efficacy of the drug given IV and CI in malignant pleural mesothelioma, non small cell lung cancer in second line, meatstatic pretreated breast cancer and pancratic cancer relapsed after conventional chemotherapy;Primary end point(s): Maximum tolerated dose (MTD) and Dose limting toxicity (DLT) | — |
Countries
Italy
Outcome results
None listed