UNASSIGNED: 7132 Background: We hypothesized that @entity2816 improves the response and @entity137 profile of chemotherapy with @entity3003 and @entity2600 because of its novel mechanism of action (anti-angiogenic, anti-neoplastic, anti-inflammatory) which is different from classic chemotherapy and because it causes @entity1142 which may counteract @entity294 of @entity2600 . METHODS: Treatment consists of @entity3003 AUC = 5 iv over 30 min day 1 and @entity2600 50 mg/m(2) iv over 90 min day 1 and 8 q 21 days. @entity2816 is given continuously po qhs starting on day 1 until progressive disease; the starting dose is 200 mg/d which is escalated by 100 mg per week if tolerated (max. 1,000 mg/d). The objectives are to determine the response rate, time to progression, overall survival, and @entity137 profile. Key eligibility criteria: @entity1149 stage IIIB ( @entity3483 ) and IV; measurable disease; no prior chemotherapy; prior radiation only allowed for brain @entity3 , neurologically stable; performance status (PS) 0-1; adequate hematologic, hepatic and renal function. RESULTS: So far, 36 @entity1 have been entered, but 2 never received protocol treatment; characteristics of 34 treated @entity1 : median age 65 (47-79); female/male 8/26; black/white 2/32; PS 0/1 in 10/24; stage 3/4 in 6/28. 23 @entity1 are evaluable for response: partial 5 (22%), stable 12 (52%). The median time to progression is 3.6 months (95% CI, 2.3-4.9). 19 of 34 @entity1 have died. The median survival time is 7.3 months (95% CI, 3.4-14.2). Frequent @entity137 are @entity1398 (grade 3/4 in 20%/8%), @entity1295 /malaise (grade 3/4 in 16%/4%), and @entity390 /vomiting (grade 3/4 in 20%/0%). @entity294 grade 3/4 occurred in 4%/4%. No @entity1 had lethal @entity137 . CONCLUSIONS: Treatment with @entity3003 , @entity2600 , and @entity2816 on this regimen is tolerable with reversible @entity1398 as the major @entity137 . Accrual to this study continues to more firmly establish the objective response rate and survival time. *Supported by NCI grant U10CA81851-04 [Table: see text].

Phase II study of @entity3003 , XXXX , and @entity2816 in @entity1 with advanced @entity1149 ( @entity1149 ).

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity2600 :: ('MESH:C051890', 'Chemical') :: ['irinotecan'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity3003 :: ('MESH:D016190', 'Chemical') :: ['carboplatin'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea', 'Diarrhea'] @entity2816 :: ('MESH:D013792', 'Chemical') :: ['Thalidomide', 'thalidomide'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC'] @entity1295 :: ('MESH:D005221', 'Disease') :: ['fatigue'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastasis'] @entity3483 :: ('MESH:D016066', 'Disease') :: ['malignant pleural effusion'] @entity1142 :: ('MESH:D003248', 'Disease') :: ['constipation']
@entity2600 :: (MESH:C051890,Chemical) :: ['irinotecan']
