Clinical trial NCT00705874
Conditions: Cancer
Keywords: cancer advanced cancer solid tumors lymphoma CGC-11047
Sponsor: Progen Pharmaceuticals
Start date: 2006-05-01; Completion date: 2011-09-01
Enrollment: 172 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will aims to determine the maximum tolerated dose of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated until the maximum tolerated dose is established.

Detailed description:
This study will use a dose escalation design to determine the MTD of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated in cohorts of 3 patients and dose escalation can proceed in each treatment group independent of dose escalation in the other treatment groups. CGC-11047 will be administered IV over 60 minutes and the doses of gemcitabine, docetaxel, bevacizumab, cisplatin, 5-flurouracil or sunitinib will remain fixed according to their respective product labeling.

Arms: arm 1: CGC-11047 in combination with Gemcitabine arm 2: CGC-11047 in combination with Docetaxel arm 3: CGC-11047 in combination with Bevacizumab arm 4: CGC-11047 in combination with Erlotinib arm 5: Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. arm 6: CGC-11047 in combination with 5-Flurouracil / Leucovorin arm 7: CGC-11047 in combination with Sunitinib
Interventions: intervention 1: CGC-11047 and gemcitabine intervention 2: CGC-11047 and docetaxel intervention 3: CGC-11047 and bevacizumab intervention 4: CGC-11047 and erlotinib intervention 5: CGC-11047 and cisplatin intervention 6: CGC-11047 and 5-flurouracil / leucovorin intervention 7: CGC-11047 and sunitinib
Intervention descriptions: intervention 1: Gemcitabine: (Closed to enrollment) 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle. CGC-11047 will only be given on days 1 and 15 of each cycle and will start at dose level -1 (50 mg). intervention 2: Docetaxel: (Closed to enrollment) 75 mg/m2 administered IV over 60 minutes every 21 days. CGC-11047 will be administered only on Day 1 of each 21-day cycle and will start at dose level -1 (50 mg). intervention 3: Bevacizumab: 5 mg/kg administered IV once every 14 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. intervention 4: Erlotinib: 150 mg taken orally every day of each 28-day cycle. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. intervention 5: Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. intervention 6: 5-Flurouracil / Leucovorin: Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 wks, repeated every 56 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. intervention 7: Sunitinib: 50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle). CGC-11047 will be administered on Days 1 and 8 of a 21 day cycle.

Protocol documents: