Status:
COMPLETED
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
Lead Sponsor:
Progen Pharmaceuticals
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-flurouraci...
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-fluro...
Eligibility Criteria
Inclusion
- non-hematological advanced solid tumor malignancy or lymphoma where no curative therapy exists in which monotherapy with gemcitabine or docetaxel or bevacizumab or erlotinib or cisplatin, or 5-flurouracil or sunitinib would otherwise be warranted.
- measurable disease based on radiographic evaluation or elevated tumor markers.
- ECOG - 0 or 1 (KPS \>70).
- Life expectancy \> 3 months.
Exclusion
- chemotherapy within 21 days or radiotherapy within 4 weeks prior to entering the study
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00705874
Start Date
May 1 2006
End Date
September 1 2011
Last Update
July 21 2016
Active Locations (12)
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1
Rocky Mountain Cancer Centre
Denver, Colorado, United States
2
Cancer Centres of Florida
Ocoee, Florida, United States, 34761
3
Central Indiana Cancer Centres
Indianapolis, Indiana, United States, 46219
4
Comprehensive Cancer Centres of Nevada
Las Vegas, Nevada, United States, 89169