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
Results First Received: November 17, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was June 2006 through March 2011, with last patient being treated May 2011. Patients were recruited through oncology clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no run-in phase. Patients were assigned to treatment arm based on their cancer type and which standard of care therapy was appropriate based on Investigators’ discreation.

Reporting Groups
  Description
PG11047/Gemcitabine PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
PG11047/Docetaxel PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
PG11047/Bevacizumab PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
PG11047/Erlotinib PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
PG11047/Cisplatin Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
PG11047/5-Flurouracil PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 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 weeks, repeated every 56 days).
PG11047/Sunitinib PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).

Participant Flow:   Overall Study
    PG11047/Gemcitabine     PG11047/Docetaxel     PG11047/Bevacizumab     PG11047/Erlotinib     PG11047/Cisplatin     PG11047/5-Flurouracil     PG11047/Sunitinib  
STARTED     12     9     34     34     48     32     3  
COMPLETED     10     8     32     33     36     28     3  
NOT COMPLETED     2     1     2     1     12     4     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PG11047/Gemcitabine PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
PG11047/Docetaxel PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
PG11047/Bevacizumab PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
PG11047/Erlotinib PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
PG11047/Cisplatin Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
PG11047/5-Flurouracil PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 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 weeks, repeated every 56 days).
PG11047/Sunitinib PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
Total Total of all reporting groups

Baseline Measures
    PG11047/Gemcitabine     PG11047/Docetaxel     PG11047/Bevacizumab     PG11047/Erlotinib     PG11047/Cisplatin     PG11047/5-Flurouracil     PG11047/Sunitinib     Total  
Number of Participants  
[units: participants]
  12     9     34     34     48     32     3     172  
Age  
[units: participants]
               
<=18 years     0     0     0     0     0     0     0     0  
Between 18 and 65 years     8     4     26     20     31     20     1     110  
>=65 years     4     5     8     14     17     12     2     62  
Age  
[units: years]
Mean ± Standard Deviation
  58.3  ± 10.8     63.2  ± 13.1     56.3  ± 12.8     62.8  ± 11.0     59.8  ± 10.1     60.2  ± 12.2     60.0  ± 24.4     59.8  ± 11.7  
Gender  
[units: participants]
               
Female     7     5     15     18     19     14     2     80  
Male     5     4     19     16     29     18     1     92  
Region of Enrollment  
[units: participants]
               
United States     12     9     34     34     48     32     3     172  



  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: End of Study ]

2.  Secondary:   Drug Safety   [ Time Frame: Ongoing ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Pharmacokinetics   [ Time Frame: End of Study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: Progen Pharmaceuticals Pty Ltd
phone: +61 7 32739133
e-mail: darrynb@progen-pharma.com


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