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:
Progen Pharmaceuticals
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Cisplatin
Levoleucovorin
Gemcitabine
Docetaxel
Gemcitabine hydrochloride
Erlotinib hydrochloride
Erlotinib
Bevacizumab
Sunitinib malate
Sunitinib
U.S. FDA Resources
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:
- 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 [ 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:
|
|
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:
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 May 21, 2013