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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

Primary Purpose

Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CGC-11047 and gemcitabine
CGC-11047 and docetaxel
CGC-11047 and bevacizumab
CGC-11047 and erlotinib
CGC-11047 and cisplatin
CGC-11047 and 5-flurouracil / leucovorin
CGC-11047 and sunitinib
Sponsored by
Progen Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring cancer, advanced cancer, solid tumors, lymphoma, CGC-11047

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rocky Mountain Cancer Centre
  • Cancer Centres of Florida
  • Central Indiana Cancer Centres
  • Comprehensive Cancer Centres of Nevada
  • New York Oncology Hematology PC
  • Dayton Oncology and Hematology, PA
  • Cancer Centres of the Carolinas
  • Texas Oncology, PA
  • Tyler Cancer Centre
  • Virginia Oncology Associates
  • Northwest Cancer Specialists - Vancouver Cancer Centre
  • North Star Lodge Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

7

Arm Description

CGC-11047 in combination with Gemcitabine

CGC-11047 in combination with Docetaxel

CGC-11047 in combination with Bevacizumab

CGC-11047 in combination with Erlotinib

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 in combination with 5-Flurouracil / Leucovorin

CGC-11047 in combination with Sunitinib

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD)
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

Secondary Outcome Measures

Drug Safety
Pharmacokinetics

Full Information

First Posted
June 23, 2008
Last Updated
June 21, 2016
Sponsor
Progen Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00705874
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Progen Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
cancer, advanced cancer, solid tumors, lymphoma, CGC-11047

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CGC-11047 in combination with Gemcitabine
Arm Title
2
Arm Type
Experimental
Arm Description
CGC-11047 in combination with Docetaxel
Arm Title
3
Arm Type
Experimental
Arm Description
CGC-11047 in combination with Bevacizumab
Arm Title
4
Arm Type
Experimental
Arm Description
CGC-11047 in combination with Erlotinib
Arm Title
5
Arm Type
Experimental
Arm Description
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.
Arm Title
6
Arm Type
Experimental
Arm Description
CGC-11047 in combination with 5-Flurouracil / Leucovorin
Arm Title
7
Arm Type
Experimental
Arm Description
CGC-11047 in combination with Sunitinib
Intervention Type
Drug
Intervention Name(s)
CGC-11047 and gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
CGC-11047 and docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
CGC-11047 and bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CGC-11047 and erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CGC-11047 and cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CGC-11047 and 5-flurouracil / leucovorin
Other Intervention Name(s)
5-FU, Florouracil, Efudix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CGC-11047 and sunitinib
Other Intervention Name(s)
Sutent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
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
Time Frame
End of Study
Secondary Outcome Measure Information:
Title
Drug Safety
Time Frame
Ongoing
Title
Pharmacokinetics
Time Frame
End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Stephenson, MD
Organizational Affiliation
Cancer Centres of the Carolinas, Greenville, SC 29605
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Cancer Centre
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Cancer Centres of Florida
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Central Indiana Cancer Centres
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Comprehensive Cancer Centres of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
New York Oncology Hematology PC
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Dayton Oncology and Hematology, PA
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Cancer Centres of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Texas Oncology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Tyler Cancer Centre
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Northwest Cancer Specialists - Vancouver Cancer Centre
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
North Star Lodge Cancer Centre
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.progen.com.au
Description
Progen Pharmaceuticals website

Learn more about this trial

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

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