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A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Dose Limiting Toxicity, Safety and Pharmacokinetics 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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Dose Limiting Toxicity, Safety and Pharmacokinetics 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


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.


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

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: Any nonhematologic toxicity > Grade 3 lasting > 3 days Grade 4 thrombocytopenia Grade 4 Anemia on the next scheduled dosing day Grade 4 Neutropenia (lasting > than 5 days Any febrile neutropenia (Grade 3 or 4)) Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity

Outcome Time Frame:

End of Study

Safety Issue:

No

Principal Investigator

Joe Stephenson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Centres of the Carolinas, Greenville, SC 29605

Authority:

United States: Food and Drug Administration

Study ID:

47-01-002

NCT ID:

NCT00705874

Start Date:

May 2006

Completion Date:

September 2011

Related Keywords:

  • Cancer
  • cancer
  • advanced cancer
  • solid tumors
  • lymphoma
  • CGC-11047
  • Lymphoma

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Texas Oncology, PADallas, Texas  75246-2006
Rocky Mountain Cancer CentreDenver, Colorado  
Cancer Centres of FloridaOcoee, Florida  34761
Central Indiana Cancer CentresIndianapolis, Indiana  46219
Comprehensive Cancer Centres of NevadaLas Vegas, Nevada  89169
New York Oncology Hematology PCAlbany, New York  12206
Dayton Oncology and Hematology, PAKettering, Ohio  45409
Cancer Centres of the CarolinasGreenville, South Carolina  29605
Tyler Cancer CentreTyler, Texas  75702
Northwest Cancer Specialists - Vancouver Cancer CentreVancouver, Washington  98684
North Star Lodge Cancer CentreYakima, Washington  98902