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

June 21, 2016 updated by: Progen Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States
        • Rocky Mountain Cancer Centre
    • Florida
      • Ocoee, Florida, United States, 34761
        • Cancer Centres of Florida
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Central Indiana Cancer Centres
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centres of Nevada
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology PC
    • Ohio
      • Kettering, Ohio, United States, 45409
        • Dayton Oncology and Hematology, PA
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centres of the Carolinas
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology, PA
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Centre
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists - Vancouver Cancer Centre
      • Yakima, Washington, United States, 98902
        • North Star Lodge Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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
  • Efudix
  • Florouracil
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 Names:
  • Sutent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: End of Study

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
End of Study

Secondary Outcome Measures

Outcome Measure
Time Frame
Drug Safety
Time Frame: Ongoing
Ongoing
Pharmacokinetics
Time Frame: End of Study
End of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progen Pharmaceuticals

Investigators

  • Principal Investigator: Joe Stephenson, MD, Cancer Centres of the Carolinas, Greenville, SC 29605

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 26, 2008

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47-01-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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