Clinical trial NCT00705874: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: cancer
advanced cancer
solid tumors
lymphoma
CGC-11047
Lead sponsor: Progen Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated until the maximum tolerated dose is established.

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-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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: End of Study
Secondary outcomes:
measure: Drug Safety
timeFrame: Ongoing
measure: Pharmacokinetics
timeFrame: End of Study
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Centre
state: Colorado
city: Ocoee
country: United States
facility: Cancer Centres of Florida
state: Florida
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centres
state: Indiana
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centres of Nevada
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology PC
state: New York
city: Kettering
country: United States
facility: Dayton Oncology and Hematology, PA
state: Ohio
city: Greenville
country: United States
facility: Cancer Centres of the Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Centre
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists - Vancouver Cancer Centre
state: Washington
city: Yakima
country: United States
facility: North Star Lodge Cancer Centre
state: Washington
Study officials:
affiliation: Cancer Centres of the Carolinas, Greenville, SC 29605
name: Joe Stephenson, MD
role: PRINCIPAL_INVESTIGATOR
References: