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Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00069160
First received: September 15, 2003
Last updated: September 12, 2012
Last verified: September 2012
Results First Received: June 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lung Neoplasms
Ovarian Neoplasms
Cervix Neoplasms
Renal Neoplasms
Interventions: Drug: docetaxel
Drug: tariquidar
Other: 99mTc-sestamibi imaging

  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
Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22 Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22 Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.

Participant Flow:   Overall Study
    Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22     Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22  
STARTED     23     25  
COMPLETED     23     25  
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
Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22 Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22 Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
Total Total of all reporting groups

Baseline Measures
    Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22     Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22     Total  
Number of Participants  
[units: participants]
  23     25     48  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19     20     39  
>=65 years     4     5     9  
Age  
[units: years]
Mean ± Standard Deviation
  50.76  ± 9.54     55.77  ± 9.57     53.37  ± 9.79  
Gender  
[units: participants]
     
Female     18     20     38  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     23     25     48  



  Outcome Measures
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1.  Primary:   Geometric Mean of Maximum Concentration of the Drug (Cmax)   [ Time Frame: 24 hours ]

2.  Primary:   The Number of Participants With Adverse Events.   [ Time Frame: 4 yrs 8-11 months ]

3.  Primary:   Geometric Mean of Area Under Curve (AUC0)-24   [ Time Frame: 24 hours ]

4.  Primary:   Clinical Response Rate   [ Time Frame: 4 years, 8-11 months ]

5.  Secondary:   Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar   [ Time Frame: 3 - 24 hours ]

6.  Secondary:   Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue   [ Time Frame: 3-24 hours ]


  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
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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 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: Susan E. Bates, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-402-1357
e-mail: BatesS@mail.nih.gov


Publications:

Responsible Party: Susan E. Bates, National Cancer Institute (NCI), National Institutes of Health (NIH)
ClinicalTrials.gov Identifier: NCT00069160     History of Changes
Obsolete Identifiers: NCT00072202
Other Study ID Numbers: 030284, 03-C-0284, 030284
Study First Received: September 15, 2003
Results First Received: June 30, 2011
Last Updated: September 12, 2012
Health Authority: United States: Federal Government