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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
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).
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).
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.
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.
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.
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.
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.
Rocky Mountain Cancer Centre
Denver, Colorado, United States
Cancer Centres of Florida
Ocoee, Florida, United States
Central Indiana Cancer Centres
Indianapolis, Indiana, United States
Comprehensive Cancer Centres of Nevada
Las Vegas, Nevada, United States
New York Oncology Hematology PC
Albany, New York, United States
Dayton Oncology and Hematology, PA
Kettering, Ohio, United States
Cancer Centres of the Carolinas
Greenville, South Carolina, United States
Texas Oncology, PA
Dallas, Texas, United States
Tyler Cancer Centre
Tyler, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
...and 2 more locations
Maximum Tolerated Dose (MTD)
The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT). DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047: 1. Any nonhematologic toxicity \> Grade 3 lasting \> 3 days 2. Grade 4 thrombocytopenia 3. Grade 4 Anemia on the next scheduled dosing day 4. Grade 4 Neutropenia (lasting \> than 5 days 5. Any febrile neutropenia (Grade 3 or 4)) 6. Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity
Time frame: End of Study
Drug Safety
Time frame: Ongoing
Pharmacokinetics
Time frame: End of Study
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