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 - Full Text View

Sponsor:	Progen Pharmaceuticals
Information provided by:	Progen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00705874

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 I

Study Type:	Interventional
Study Design:	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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	196
Study Start Date:	May 2006
Estimated Study Completion Date:	September 2011
Estimated 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

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:

Progen Pharmaceuticals website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mr Michael Fitzgerald, Progen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00705874 History of Changes
Other Study ID Numbers:	47-01-002
Study First Received:	June 23, 2008
Last Updated:	June 13, 2011
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 February 09, 2012