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Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00489359
First received: June 19, 2007
Last updated: May 17, 2011
Last verified: May 2011
History of Changes
Results First Received: February 17, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Primary Peritoneal Cancer
Interventions: Drug: Pemetrexed - Phase 1
Drug: Carboplatin - Phase 1
Drug: Pemetrexed - Phase 2
Drug: Carboplatin - Phase 2

  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
Phase 1 and Phase 2 were conducted in different participants (i.e., Phase 1 participants did not also participate in Phase 2).

Reporting Groups
  Description
Pemetrexed/Carboplatin Phase 1 Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
Pemetrexed/Carboplatin Phase 2 Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Participant Flow:   Overall Study
    Pemetrexed/Carboplatin Phase 1     Pemetrexed/Carboplatin Phase 2  
STARTED     20     66  
COMPLETED     13 [1]   37 [1]
NOT COMPLETED     7     29  
Death                 0                 2  
Progressive Disease                 5                 6  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 1                 5  
Adverse Event                 0                 16  
[1] Received at least 6 cycles of therapy. Not completed implies participant received <6 cycles.



  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
Pemetrexed/Carboplatin Phase 1 Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
Pemetrexed/Carboplatin Phase 2 Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Total Total of all reporting groups

Baseline Measures
    Pemetrexed/Carboplatin Phase 1     Pemetrexed/Carboplatin Phase 2     Total  
Number of Participants  
[units: participants]
 		  20     66     86  
Age  
[units: years]
Mean (Standard Deviation) 		  56.99  (11.06)     57.71  (10.44)     57.54  (10.52)  
Gender  
[units: participants]
 		     
Female     20     66     86  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
 		     
Caucasian     20     59     79  
Hispanic     0     7     7  
Region of Enrollment  
[units: participants]
 		     
Canada     0     7     7  
Argentina     0     14     14  
Poland     0     5     5  
Germany     20     31     51  
Sweden     0     9     9  
Performance Status [1]
[units: participants]
 		     
ECOG Status 0     3     46     49  
ECOG Status 1     17     20     37  
Tumor Type  
[units: participants]
 		     
Ovarian Cancer     15     61     76  
Peritoneal Cancer     5     5     10  
Platinum-free interval [2]
[units: participants]
 		     
<6 months     0     3     3  
6-12 months     6     23     29  
>12 months     14     40     54  
[1]

The Eastern Cooperative Oncology Group (ECOG) score is an overall assessment of the functional/physical performance of the patient. Scores are:

0=Fully active, able to carry on all pre-disease performance without restriction. 1=Restricted in strenuous activity but ambulatory and able to carry out work of a sedentary nature. 2=Ambulatory and capable of self care but unable to carry out any work activities: up and about more than 50% of time. 3=Capable of only limited self care, confined to bed or chair more than 50% of waking hours. 4=Completely disabled, cannot carry on any self care.
[2] The time elapsed since completing platinum-based therapy.



  Outcome Measures
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1.  Primary:   Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin   [ Time Frame: First treatment to toxicity (up to 18 months) ]
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2.  Primary:   Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)   [ Time Frame: baseline to measured progressive disease (PD) (up to 18 months) ]
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3.  Secondary:   Phase 1 - Number of Dose-Limiting Toxicities (DLTs)   [ Time Frame: baseline through end of Phase 1 (up to 18 months) ]
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4.  Secondary:   Phase 1 - Number of Participants With Adverse Events (Toxicity)   [ Time Frame: baseline measured to progressive disease (up to 18 months) ]
  Show Outcome Measure 4

5.  Secondary:   Phase 1 - Recommended Dose of Pemetrexed for Phase 2   [ Time Frame: baseline measured to progressive disease (up to 18 months) ]
  Show Outcome Measure 5

6.  Secondary:   Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2   [ Time Frame: baseline measured to progressive disease (up to 18 months) ]
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7.  Secondary:   Phase 1 - Number of Participants With Tumor Response   [ Time Frame: baseline measured to progressive disease (up to 18 months) ]
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8.  Secondary:   Phase 2 - Time to Response (TTR)   [ Time Frame: First treatment to response (up to 31 months) ]
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9.  Secondary:   Phase 2 - Duration of Response (DOR)   [ Time Frame: time of response to progressive disease (up to 31 months) ]
  Show Outcome Measure 9

10.  Secondary:   Phase 2 - Time to Disease Progression   [ Time Frame: baseline to measured progressive disease (up to 31 months) ]
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11.  Secondary:   Phase 2 - Time to Treatment Failure   [ Time Frame: First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months) ]
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12.  Secondary:   Phase 2 - Overall Survival   [ Time Frame: baseline to date of death from any cause (up to 31 months) ]
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13.  Secondary:   Phase 2 - Number of Participants With Adverse Events (Toxicity)   [ Time Frame: baseline through end of Phase 2 (up to 31 months) ]
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14.  Secondary:   Phase 2 - Progression-Free Survival   [ Time Frame: baseline to measured progressive disease (up to 31 months) ]
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  Serious Adverse Events
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  Other Adverse Events
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  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
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  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 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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications:
Bookman MA. 2006. GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. J Clin Oncol 24 (suppl 18S). Abstract 5002.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00489359     History of Changes
Other Study ID Numbers: 9516
H3E-MC-JMHH ( Other Identifier: Eli Lilly and Company )
Study First Received: June 19, 2007
Results First Received: February 17, 2011
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration