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Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00083122
First received: May 14, 2004
Last updated: May 6, 2014
Last verified: April 2013
Results First Received: March 22, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Primary Peritoneal Cavity Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Primary Peritoneal Cavity Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer
Interventions: Drug: cisplatin
Drug: alvocidib
Drug: cisplatin/flavopiridol

  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
Forty-five patients were enrolled between December 23, 2004 and February 25, 2010: 40 patients to Group 1 (platin resistant; 14 evaluable, 26 measurable) and 5 patients to Group 2 (platin sensitive; 1 evaluable, 4 measurable). Group 2 was closed on 03/10/2006 due to poor accrual.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who progressed or relapsed during or within 6 months of primary platinum-based therapy constituted Group 1 (“Platin Resistant”). Participants who relapsed > 6 months following completion of platinum-based therapy, and who had received only a single prior chemotherapy regimen constituted Group 2 (“Platin Sensitive”).

Reporting Groups
  Description
Group 1 (Platin Resistant) Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group 2 (Platin Sensitive) Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Group 1 (Platin Resistant)     Group 2 (Platin Sensitive)  
STARTED     40     5  
COMPLETED     40     5  
NOT COMPLETED     0     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
Group 1 (Platin Resistant) Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group 2 (Platin Sensitive) Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Group 1 (Platin Resistant)     Group 2 (Platin Sensitive)     Total  
Number of Participants  
[units: participants]
  40     5     45  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 29 to 79 )  
  61  
  ( 41 to 73 )  
  59  
  ( 29 to 79 )  
Gender  
[units: participants]
     
Female     40     5     45  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     40     5     45  



  Outcome Measures
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1.  Primary:   Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)   [ Time Frame: 24 weeks ]

2.  Secondary:   Overall Survival   [ Time Frame: Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years ]

3.  Secondary:   Time to Progression   [ Time Frame: Time from registration to the date of progression or last follow-up, assessed up to 3 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
No text entered.


  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: Keith C. Bible, M.D, Ph.D.
Organization: Mayo Clinic Cancer Center
e-mail: Bible.Keith@mayo.edu


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00083122     History of Changes
Other Study ID Numbers: NCI-2009-00029, NCI-2009-00029, CDR0000363562, MC0261, 5876, N01CM62205, P30CA015083
Study First Received: May 14, 2004
Results First Received: March 22, 2013
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration