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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Page 1 of 3 (12 locations)

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