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| Sponsored by: |
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: | Treatment, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
| 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 |
| Estimated Enrollment: | 196 |
| Study Start Date: | May 2006 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
CGC-11047 in combination with Gemcitabine
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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).
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2: Experimental
CGC-11047 in combination with Docetaxel
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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).
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3: Experimental
CGC-11047 in combination with Bevacizumab
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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.
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4: Experimental
CGC-11047 in combination with Erlotinib
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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.
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5: Experimental
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.
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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.
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6: Experimental
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.
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7: Experimental
CGC-11047 in combination with Sunitinib
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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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Patient Enquiries, Progen Pharmaceuticals | patient.enquiries@progen-pharma.com |
| United States, Colorado | |
| Rocky Mountain Cancer Centre | Recruiting |
| Denver, Colorado, United States | |
| Contact: Sylvia Mosher, MD 303-285-5081 | |
| Principal Investigator: Michele Basche, MD | |
| United States, Florida | |
| Cancer Centres of Florida | Recruiting |
| Ocoee, Florida, United States, 34761 | |
| Contact: Mary C Kelley, RN 407-339-6974 | |
| Contact: Lynn Hogue 407-658-9532 | |
| Principal Investigator: Carlos Alemany, MD | |
| United States, Indiana | |
| Central Indiana Cancer Centres | Recruiting |
| Indianapolis, Indiana, United States, 46219 | |
| Contact: Yvonne LaFary, RN 317-964-5200 | |
| Contact: Tiffany Fox 317-964-5200 | |
| Principal Investigator: David Loesch, MD | |
| United States, Nevada | |
| Comprehensive Cancer Centres of Nevada | Recruiting |
| Las Vegas, Nevada, United States, 89169 | |
| Contact: Elizabeth Petersen, RN 702-952-3426 | |
| Principal Investigator: Matthew Galsky, MD | |
| United States, New York | |
| New York Oncology Hematology PC | Recruiting |
| Albany, New York, United States, 12206 | |
| Contact: Michele Butler, RN 518-489-2607 | |
| Contact: Joanna Walsh, RN 518-262-6696 | |
| Principal Investigator: Lawrence Garbo, MD | |
| United States, Ohio | |
| Dayton Oncology and Hematology, PA | Recruiting |
| Kettering, Ohio, United States, 45409 | |
| Contact: Michelle Owens, RN 937-528-0317 | |
| Contact: Mary McCreary, RN 937-528-0316 | |
| Principal Investigator: Robert Raju | |
| United States, South Carolina | |
| Cancer Centres of the Carolinas | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Julie Martin, APRN, NP 864-679-3966 | |
| Principal Investigator: Joe Stephenson, MD | |
| United States, Texas | |
| Tyler Cancer Centre | Recruiting |
| Tyler, Texas, United States, 75702 | |
| Contact: Linda Dunklin, RN 903-579-9867 | |
| Contact: Karen Poe, RN 903-579-9800 | |
| Principal Investigator: Don Richards, MD | |
| Texas Oncology, PA | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Ben Garcia, RN 214-370-1949 | |
| Principal Investigator: Carlos Becerra, MD | |
| United States, Virginia | |
| Virginia Oncology Associates | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Contact: Catherine Sellars, RN 757-213-5658 | |
| Principal Investigator: Paul Conkling, MD | |
| United States, Washington | |
| Northwest Cancer Specialists - Vancouver Cancer Centre | Recruiting |
| Vancouver, Washington, United States, 98684 | |
| Contact: Judy Welsh, RN 360-449-6522 | |
| Principal Investigator: David Smith, MD | |
| North Star Lodge Cancer Centre | Recruiting |
| Yakima, Washington, United States, 98902 | |
| Contact: Beth Parker, RN 509-574-3493 | |
| Principal Investigator: Thomas Boyd, MD | |
| Principal Investigator: | Joe Stephenson, MD | Cancer Centres of the Carolinas, Greenville, SC 29605 |
More Information
| Responsible Party: | Progen Pharmaceuticals ( Mr Michael Fitzgerald ) |
| Study ID Numbers: | 47-01-002 |
| Study First Received: | June 23, 2008 |
| Last Updated: | March 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00705874 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
cancer advanced cancer solid tumors lymphoma CGC-11047 |
|
Antimetabolites Erlotinib Vitamin B Complex Immunoproliferative Disorders Immunologic Factors Leucovorin Trace Elements Bevacizumab Protein Kinase Inhibitors Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents |
Docetaxel Lymphatic Diseases Cisplatin Radiation-Sensitizing Agents Sunitinib Vitamins Fluorouracil Micronutrients Lymphoproliferative Disorders Gemcitabine Lymphoma |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin Bevacizumab Protein Kinase Inhibitors Docetaxel Cisplatin Sunitinib Therapeutic Uses Vitamins |
Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Gemcitabine Lymphoma Erlotinib Immunoproliferative Disorders Neoplasms by Histologic Type Vitamin B Complex Immune System Diseases Growth Substances Enzyme Inhibitors Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents |
