PHASE II MULTICENTRIC STUDY OF SEQUENTIAL CHEMOTHERAPY WITH GEMCITABINE FOLLOWED FROM DOCETAXEL IN ELDERLY PATIENTS WITH NOT SMALL CELLS LUNG CANCER NSCLC ADVANCED - POLTO-Elderly04

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001260-31-IT

Enrollment

Registered

2006-03-13

Start date

2005-06-09

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SEQUENTIAL CHEMOTHERAPY IMPROVED THE ACTYVITY OF DOCETAXEL IN ELDERLY PATIENTS WITH NSCLC ADVANCED MedDRA version: 6.1 Level: PT Classification code 10029522

Interventions

Trade Name: GEMZAR 1G POLV. EV 1 FL Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Gemcitabine CAS Number: 122111-03-9 Concentration unit: mg milligram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: pulmonary histologic or cytological Diagnosis of NSLC measurable Disease second criteria RECIST Stage IIIB for cytologically positive pleuric deposit or sopraclavearic metastases Stage IV Age 70 years ECOG performance status 0 - 2 Expected life 3 months Adapted medullary functionality leucociti 4,0 x109/L, neutrophil 2,0 x 109/L, 100 plt x 109/L, emoglobina 10 g/dL Adapted renal hepatic functionality and bilirubinemia 1,2 mg/dL, transaminases 2,5 x VN, creatininemia 1,5 mg/dL informed Consent written Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Diagnosi the brought back criteria inel protocol of other malignant neoplasie in last the 5 years except the carcinoma in situ of the cervix uterina and the basalioma or ca. to spinocellulare cutaneous adequately deals Previous chemotherapy to you for the metastatic disease Radioterapy on the neoplastic lesions cerebral Metastase sintomatic scompensate metabolic Diseases or infections in action cardiac Aritmye or ischemic cardiopathy not controlled impossibility to execute an adequate one follow-up

Design outcomes

Primary

Measure	Time frame
Main Objective: To EVALUATE the activity antitumor of the sequenTial treatment;Secondary Objective: to evaluate the toxicity of the sequential treatment - to evaluate TTP- to evaluate the OS and percentage of patients survival to a year;Primary end point(s): percentage of RO	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026