Pretreated patients with advanced colorectal cancer MedDRA version: 14.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: PEMETREXED
CAS Number: 137281-23-3
Current Sponsor code: PEM
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologic or cytologic confirmed diagnosis of colorectal carcinoma with metastatic (STAGE IV) disease. 2.Measurable disease according to RECIST criteria (see Appendix C). 3.Prior chemotherapy for metastatic disease is required; prior regimens (in adjuvant oral advanced stage setting) must include 5fluorouracile, Oxaliplatin and Irinotecan if not contraindicated. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 2.Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 3.Previous treatment with Gemcitabine or Pemetrexed. 4.History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gemcitabine and/or Pemetrexed or other agents used in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the objective response rate (ORR: CR+PR+SD);Secondary Objective: - to assess safety and tolerability of the drugs combination; - to determine the time to progression (TTP) and overall survival (OS) of treated patients;Primary end point(s): The primary endpoint of the study is to assess the objective response rate (ORR: CR+PR+SD) in treated patients.;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are toxicity, time to progression (TTP) and overall survival (OS).;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public Contactdata manager
IRST
Outcome results
None listed