Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary

This study has been terminated.
(Due to funding provided for Phase II portion of trial)
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201734
First received: September 12, 2005
Last updated: June 1, 2016
Last verified: June 2016
Results First Received: April 25, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Tumors
Unknown Primary Tumors
Adenocarcinoma
Interventions: Drug: Capecitabine
Drug: Carboplatin
Drug: 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
Patients were enrolled to the trial between July 2005 and November 2007

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
Phase I Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
Phase II Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.

Participant Flow:   Overall Study
    Phase I     Phase II  
STARTED     35     25  
Patients Not Eligible     3     0  
COMPLETED     32     25  
NOT COMPLETED     3     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
Phase I Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
Phase II Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
Total Total of all reporting groups

Baseline Measures
    Phase I     Phase II     Total  
Number of Participants  
[units: participants]
  32     25     57  
Age  
[units: patients]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     21     49  
>=65 years     4     4     8  
Gender  
[units: patients]
     
Female     6     12     18  
Male     26     13     39  
Race (NIH/OMB)  
[units: patients]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     1     3  
White     29     24     53  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: patients]
     
United States     32     25     57  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose in Phase I Portion of Study   [ Time Frame: Every 3 weeks, for up to 24 weeks ]

2.  Primary:   Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design.   [ Time Frame: Every 3 weeks, for up to 24 weeks ]

3.  Secondary:   Phase I: To Determine Side Effects   [ Time Frame: Every 3 weeks, for up to 24 weeks ]

4.  Secondary:   Progression-Free Survival at 6 Months for Patients   [ Time Frame: up to 6 years ]

5.  Secondary:   One Year Survival for Patients   [ Time Frame: Up to 1 year ]

6.  Secondary:   Time to Tumor Progression for Patients   [ 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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Tanios Bekaii-Saab, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-9863
e-mail: tanios.bekaii-saab@osumc.edu


Publications:

Responsible Party: Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201734     History of Changes
Other Study ID Numbers: OSU-0317
NCI-2011-03593 ( Registry Identifier: Clinical Trials Reporting Program )
Study First Received: September 12, 2005
Results First Received: April 25, 2016
Last Updated: June 1, 2016
Health Authority: United States: Institutional Review Board