Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma (XAGastric)

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Sanofi
Genentech, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00447330
First received: March 13, 2007
Last updated: January 28, 2015
Last verified: July 2014
Results First Received: January 20, 2015  
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: Esophageal Neoplasms
Stomach Neoplasms
Neoplasm Metastasis
Intervention: Drug: capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin)

  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
81 subjects consented, 21 were screen failures, 60 subjects were considered enrolled.

Reporting Groups
  Description
1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti

capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.

Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.

Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.


Participant Flow:   Overall Study
    1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti  
STARTED     60 [1]
COMPLETED     58  
NOT COMPLETED     2  
[1] 2 subjects signed the ICF, but were withdrawn from study prior to receiving any study drug



  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.
Number of subjects receiving study drug

Reporting Groups
  Description
1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin

capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.

Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.

Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.


Baseline Measures
    1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin  
Number of Participants  
[units: participants]
  60  
Age  
[units: years]
Mean ± Standard Deviation
  58  ± 12  
Gender  
[units: participants]
 
Female     13  
Male     47  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Progression-Free Survival (PFS)   [ Time Frame: 5 years from study start date ]

2.  Secondary:   To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma   [ Time Frame: Every 21 days ]

3.  Secondary:   Response Rate   [ Time Frame: Every 9 weeks for up to 1 year ]

4.  Secondary:   Median Survival   [ Time Frame: 5 years after study start date ]


  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: Brant Hamel
Organization: Duke University Medical Center
phone: 919-668-1861
e-mail: brant.hamel@duke.edu


Publications:
Jemal, A., et al., Cancer statistics, 2005. CA Cancer J Clin, 2005. 55(1): p. 10-30.
Sumpter, K., et al. Randomised, mulitcenter phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer: confirmation of dose escalation. in Proc Am Soc Clin Onocol. 2003.
Miller, K.D., et al. E2100: A randomized phase III trial of paclitaxel versus paclitaxel plus bevacizumab as first line threapy for locally recurrent or metastatic breast cancer. in American Society for Clinical Oncology. 2005. Orlando, FL.
Goldberg, R.M., et al. N9741: oxaliplatin (Oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer (CRC). Updated efficacy and quality of life (QOL) data from an intergroup study. in Proc Am Soc Clin Oncol. 2003.
Ishitsuka, H., T. Ishikawa, and Y. Fukase. Capecitabine and the dThdPase up-regulators IFN-gamma or taxol showed synergistic activity in human cancer xenografts. in Proc Am Assoc Cancer Res. 1996.
Hurwitz, H., S.N. Holden, and S.G. Eckhardt, Clinical evaluation of ZD6474, an orally active inhibitor of VEGF signaling in patients with solid tumors. Proceedings of the American Society of Clinical Oncology, 2002. 21: p. Abstract 325.
Brookmeyer, R. and J.J. Crowley, A confidence interval for the median survival time. Biometrics, 1982. 38: p. 29-41.


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00447330     History of Changes
Other Study ID Numbers: Pro00008710, 11100, 8797
Study First Received: March 13, 2007
Results First Received: January 20, 2015
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration