Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00603538
First received: January 17, 2008
Last updated: March 5, 2013
Last verified: March 2013
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: CP-751,871 + carboplatin + paclitaxel

  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
No text entered.

Reporting Groups
  Description
CP-751,871 6 mg/kg in Combination With Chemotherapy Agents CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
CP-751,871 10 mg/kg in Combination With Chemotherapy Agents CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
CP-751,871 20 mg/kg in Combination With Chemotherapy Agents CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Participant Flow:   Overall Study
    CP-751,871 6 mg/kg in Combination With Chemotherapy Agents     CP-751,871 10 mg/kg in Combination With Chemotherapy Agents     CP-751,871 20 mg/kg in Combination With Chemotherapy Agents  
STARTED     6     7 [1]   6  
COMPLETED     3     3     4  
NOT COMPLETED     3     4     2  
Adverse Event                 0                 4                 2  
Objective progression or relapse                 3                 0                 0  
[1] Including one participant who discontinued from the study prior to CP-751,871 administration.



  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.
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Reporting Groups
  Description
CP-751,871 6 mg/kg in Combination With Chemotherapy Agents CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
CP-751,871 10 mg/kg in Combination With Chemotherapy Agents CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
CP-751,871 20 mg/kg in Combination With Chemotherapy Agents CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
Total Total of all reporting groups

Baseline Measures
    CP-751,871 6 mg/kg in Combination With Chemotherapy Agents     CP-751,871 10 mg/kg in Combination With Chemotherapy Agents     CP-751,871 20 mg/kg in Combination With Chemotherapy Agents     Total  
Number of Participants  
[units: participants]
  6     7     6     19  
Age, Customized  
[units: participants]
       
20 to 44 years     0     5     1     6  
45 to 64 years     4     2     2     8  
>=65 years     2     0     3     5  
Gender  
[units: participants]
       
Female     3     3     1     7  
Male     3     4     5     12  
ECOG Performance Status [1]
[units: participants]
       
Score 0     5     7     4     16  
Score 1     1     0     2     3  
[1] ECOG = Eastern Cooperative Oncology Group. ECOG Grade: 0: Fully active. 1: Ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of all selfcare. 3: Capable of limited selfcare, confined to bed or chair more than 50% of waking hours. 4: Completely disabled, no selfcare, totally confined to bed or chair. 5: Dead.



  Outcome Measures
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1.  Primary:   Number of Participants With Dose Limiting Toxicities (DLT)   [ Time Frame: Cycle 1 ]

2.  Secondary:   Maximum Observed Concentration (Cmax) of CP-751,871   [ Time Frame: Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]

3.  Secondary:   Plasma Decay Half-Life (t1/2)   [ Time Frame: Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]

4.  Secondary:   Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)   [ Time Frame: Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]

5.  Secondary:   Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)   [ Time Frame: Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]

6.  Secondary:   Observed Accumulation Ratio (Rac)   [ Time Frame: Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]

7.  Secondary:   Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)   [ Time Frame: Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study ]

8.  Secondary:   Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)   [ Time Frame: Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment ]

9.  Secondary:   Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.   [ Time Frame: Day 1 of Cycles 1 (predose) and 4, and end of study ]

10.  Secondary:   Number of Participants With Objective Response   [ Time Frame: Baseline up to 6 cycles (1 cycle = 21 days) ]

11.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline up to 6 cycles (1 cycle = 21 days) ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00603538     History of Changes
Other Study ID Numbers: A4021019, Japan CTPN 19-2409
Study First Received: January 17, 2008
Results First Received: January 18, 2013
Last Updated: March 5, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare