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GTI-2040 and Capecitabine in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068588
First received: September 10, 2003
Last updated: October 24, 2014
Last verified: January 2013
Results First Received: September 25, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions: Biological: GTI-2040
Drug: capecitabine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1st 3 pts treated on arm 2. If 0/3 DLTs, escalate to arm 3. If 1/3 DLTs on arm 2, 3 more pts on arm 2. If 1/6 DLTs on arm 2, escalate to arm 3.If at most 1/6 DLTs on arm 3, MTD declared. If more than 1/6 DLTs on arm 3, then de-escalated to arm 2. If at most 1/6 DLTs on arm 2, MTD declared. If more than 1/6 DLTs on arm 2, then de-escalate to arm 1.

Reporting Groups
  Description
Arm 1 Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
Arm 2 Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
Arm 3 Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,

Participant Flow:   Overall Study
    Arm 1     Arm 2     Arm 3  
STARTED     0     3     21  
COMPLETED     0     3     17  
NOT COMPLETED     0     0     4  
Adverse Event                 0                 0                 2  
Withdrawal by Subject                 0                 0                 1  
Poor KPS                 0                 0                 1  



  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
Arm 1 Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
Arm 2 Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
Arm 3 Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Arm 3     Total  
Number of Participants  
[units: participants]
  0     3     21     24  
Age  
[units: years]
Median ( Full Range )
   
   
  63  
  ( 42 to 64 )  
  52  
  ( 39 to 74 )  
  53  
  ( 39 to 74 )  
Gender  
[units: participants]
       
Female         3     21     24  
Male         0     0     0  
Region of Enrollment  
[units: participants]
       
United States         3     21     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose Determined by Dose-limiting Toxicities   [ Time Frame: 21 days ]

2.  Primary:   Response Rate of a Combination of GTI-2040 and Capecitabine   [ Time Frame: Up to 6 years ]


  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
In the first stage of the two stage Optimum design, following the dose escalation step, 3 of 15 patients responded for a response rate of 20%. A response rate of less than 25% would not warrant further study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068588     History of Changes
Other Study ID Numbers: NCI-2012-02827, PHII-46, N01CM62209, CDR0000327757
Study First Received: September 10, 2003
Results First Received: September 25, 2014
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration