Study of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma
NCT ID: NCT00705874
Last Updated: 2016-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
172 participants
INTERVENTIONAL
2006-05-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
CGC-11047 in combination with Gemcitabine
CGC-11047 and gemcitabine
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).
2
CGC-11047 in combination with Docetaxel
CGC-11047 and docetaxel
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).
3
CGC-11047 in combination with Bevacizumab
CGC-11047 and bevacizumab
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.
4
CGC-11047 in combination with Erlotinib
CGC-11047 and erlotinib
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.
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.
CGC-11047 and cisplatin
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.
6
CGC-11047 in combination with 5-Flurouracil / Leucovorin
CGC-11047 and 5-flurouracil / leucovorin
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.
7
CGC-11047 in combination with Sunitinib
CGC-11047 and sunitinib
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.
Interventions
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CGC-11047 and gemcitabine
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).
CGC-11047 and docetaxel
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).
CGC-11047 and bevacizumab
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.
CGC-11047 and erlotinib
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.
CGC-11047 and cisplatin
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.
CGC-11047 and 5-flurouracil / leucovorin
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.
CGC-11047 and sunitinib
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* measurable disease based on radiographic evaluation or elevated tumor markers.
* ECOG - 0 or 1 (KPS \>70).
* Life expectancy \> 3 months.
Exclusion Criteria
* known active brain metastases or leptomeningeal carcinomatosis.
* history of a myocardial infarction within the prior 6 months or, hospitalizations for congestive heart failure within the prior 6 months, or active treatment for uncontrolled cardiac arrhythmias
* clinically significant gastrointestinal tract hemorrhage, requiring transfusion therapy, within the prior 3 months.
18 Years
ALL
No
Sponsors
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Progen Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Joe Stephenson, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Centres of the Carolinas, Greenville, SC 29605
Locations
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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
Northwest Cancer Specialists - Vancouver Cancer Centre
Vancouver, Washington, United States
North Star Lodge Cancer Centre
Yakima, Washington, United States
Countries
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Related Links
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Progen Pharmaceuticals website
Other Identifiers
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47-01-002
Identifier Type: -
Identifier Source: org_study_id
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