Conditions: Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 53
Healthy volunteers: no

Brief summary:
This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW 2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on days 1 to 6 of a 21 day cycle.

The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in advanced cancer patients in combination therapy with pemetrexed.

Detailed description:

Arms:
arm 1: patient receives low dose tablet BIBW 2992 po daily plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 2: patient receives medium dose BIBW 2992 po daily plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 3: patient receives high dose BIBW 2992 po daily plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 4: patient receives low dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 5: patient receives medium BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 6: patient receives high dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle

Interventions: intervention 1: BIBW 2992 low dose intervention 2: BIBW 2992 high dose intervention 3: pemetrexed intervention 4: pemetrexed intervention 5: BIBW 2992 high dose 6 day intervention 6: pemetrexed intervention 7: pemetrexed intervention 8: pemetrexed intervention 9: pemetrexed intervention 10: BIBW 2992 low dose 6 day intervention 11: BIBW 2992 medium dose 6 day intervention 12: BIBW 2992 medium dose
Intervention descriptions: intervention 1: patient receives low dose BIBW 2992 po daily on day 1 of 21 day cycle intervention 2: patient receives high dose BIBW 2992 po daily on day 1 of 21 day cycle intervention 3: given intravenously on day 1 of a 21 day cycle intervention 4: given intravenously on day 1 of a 21 day cycle intervention 5: patient receives high dose BIBW 2992 po daily on days 1-6 on 1 of 21 day cycle intervention 6: given intravenously on day 1 of a 21 day cycle intervention 7: given intravenously on day 1 of a 21 day cycle intervention 8: given intravenously on day 1 of a 21 day cycle intervention 9: given intravenously on day 1 of a 21 day cycle intervention 10: patient receives low dose BIBW 2992 po daily on days 1-6 on day 1 of 21 day cycle intervention 11: patient receives medium dose BIBW 2992 po daily on day1 to 6 of a 21 day cycle intervention 12: patient receives medium dose BIBW 2992 po daily on day 1 of 21 day cycle

Protocol document: