Phase 2 study of DICb in adv. NSCLC

Aim: To test the tolerability and activity of a novel regimen combining docetaxel instead of paclitaxel and carboplatin instead of cisplatin with ifosfamide (DICb) in the outpatient setting in patients with advanced non-small cell lung cancer.

Conclusions: In the present phase II study the DICb combination yielded important activity and good tolerability in advanced NSCLC.

Official Title

A phase II study of the docetaxel- ifosfamide-carboplatin combination in advanced non-small-cell lung cancer.

Conditions

Study Type

Phase II

Study Design

DICbDocetaxel 80 mg/m2 i.v. (1h inf.) d1Ifosfamide 3500 mg/m2 i.v. (1h inf.) d1 with mesnaCarboplatin AUC=5 i.v. (30 min inf.) d1With G-CSF on an outpatients basis.

Further Details

Efficacy: CR: 4PR: 18SD: 11PD: 7Med response duration: 7 moMed TTP: 9 moMed OS: 11 mo1-y survival: 47.5%quality of life score: improved in 31 (77.5%) of patients Tolerability:Leukopenia gr3- 35%, gr4- 35%Neutropenia gr3- 40%, gr4- 30%Thrombocytopenia gr3- 7.5%, gr4- 2.5%Anaemia gr3- 5%Nausea/vomiting gr3- 10%

Study Start

40 (13 IIIb; 27 IV)

Eligibility & Criteria

Indication: Advanced non-small cell lung cancer.Eligibility: Histologically confirmed disease; stage IIIB / IV; not amenable to potentially curative surgery and / or radiotherapy: WHO PS ≤ 2; adequate hematological, liver, and renal function; no previous chemotherapy.

Total Enrolment

Contact Details

Kosmas,C.; Tsavaris,N.; Koutras,A.; Makatsoris,T.; Mylonakis,N.; Tzelepis,G.; Dimitrakopoulos,A.; Spyropoulos,K.; Polyzos,A.; Karabelis,A.; Kalofonos,H.P.3 Institutions from GreeceOncology 69 (2005): 333-341