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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Progen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00705874
First received: June 23, 2008
Last updated: January 22, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: CGC-11047 and gemcitabine
Drug: CGC-11047 and docetaxel
Drug: CGC-11047 and bevacizumab
Drug: CGC-11047 and erlotinib
Drug: CGC-11047 and cisplatin
Drug: CGC-11047 and 5-flurouracil / leucovorin
Drug: CGC-11047 and sunitinib
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Progen Pharmaceuticals:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: End of Study ] [ Designated as safety issue: No ]

    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:

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


Secondary Outcome Measures:
  • Drug Safety [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: May 2006
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CGC-11047 in combination with Gemcitabine
Drug: CGC-11047 and gemcitabine
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).
Other Name: Gemzar
Experimental: 2
CGC-11047 in combination with Docetaxel
Drug: CGC-11047 and docetaxel
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).
Other Name: Taxotere
Experimental: 3
CGC-11047 in combination with Bevacizumab
Drug: CGC-11047 and bevacizumab
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.
Other Name: Avastin
Experimental: 4
CGC-11047 in combination with Erlotinib
Drug: CGC-11047 and erlotinib
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.
Other Name: Tarceva
Experimental: 5
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.
Drug: CGC-11047 and cisplatin
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.
Experimental: 6
CGC-11047 in combination with 5-Flurouracil / Leucovorin
Drug: CGC-11047 and 5-flurouracil / leucovorin
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.
Other Names:
  • 5-FU
  • Florouracil
  • Efudix
Experimental: 7
CGC-11047 in combination with Sunitinib
Drug: CGC-11047 and sunitinib
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.
Other Name: Sutent

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705874

Locations
United States, Colorado
Rocky Mountain Cancer Centre
Denver, Colorado, United States
United States, Florida
Cancer Centres of Florida
Ocoee, Florida, United States, 34761
United States, Indiana
Central Indiana Cancer Centres
Indianapolis, Indiana, United States, 46219
United States, Nevada
Comprehensive Cancer Centres of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
New York Oncology Hematology PC
Albany, New York, United States, 12206
United States, Ohio
Dayton Oncology and Hematology, PA
Kettering, Ohio, United States, 45409
United States, South Carolina
Cancer Centres of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology, PA
Dallas, Texas, United States, 75246
Tyler Cancer Centre
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Northwest Cancer Specialists - Vancouver Cancer Centre
Vancouver, Washington, United States, 98684
North Star Lodge Cancer Centre
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Progen Pharmaceuticals
Investigators
Principal Investigator: Joe Stephenson, MD Cancer Centres of the Carolinas, Greenville, SC 29605
  More Information

Additional Information:
No publications provided

Responsible Party: Progen Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00705874     History of Changes
Other Study ID Numbers: 47-01-002
Study First Received: June 23, 2008
Results First Received: November 17, 2011
Last Updated: January 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Progen Pharmaceuticals:
cancer
advanced cancer
solid tumors
lymphoma
CGC-11047

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Docetaxel
Bevacizumab
Sunitinib
Cisplatin
Leucovorin
Levoleucovorin
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents

ClinicalTrials.gov processed this record on July 26, 2014