Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    ACOSOG Z4051
Previous Study | Return to List | Next Study

Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Amgen
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00757172
First received: September 22, 2008
Last updated: August 14, 2014
Last verified: August 2014
Results First Received: July 25, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Interventions: Biological: panitumumab
Drug: cisplatin
Drug: docetaxel
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Seventy participants were recruited between January 2009 to July 2011 from 24 institutions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five participants were declared ineligible. One participant had a celiac lymph node >2 cm and one participant had two primary tumors. Liver lesions were noted and not investigated in one participant. Two participants had Siewert type III tumors. These five participants were excluded from all analysis except adverse events.

Reporting Groups
  Description
Docetaxel + Cisplatin + Panitumumab + RT Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).

Participant Flow:   Overall Study
    Docetaxel + Cisplatin + Panitumumab + RT  
STARTED     65  
COMPLETED     54 [1]
NOT COMPLETED     11  
Withdrawal by Subject                 4  
Physician Decision                 3  
Progression                 4  
[1] Participants underwent surgery.



  Baseline Characteristics
  Hide Baseline Characteristics

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.
All registered participants who have met the eligibility criteria.

Reporting Groups
  Description
Docetaxel + Cisplatin + Panitumumab + RT Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).

Baseline Measures
    Docetaxel + Cisplatin + Panitumumab + RT  
Number of Participants  
[units: participants]
  65  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 30 to 76 )  
Gender  
[units: participants]
 
Female     6  
Male     59  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     64  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     65  
Eastern Cooperative Oncology Group (ECOG) performance status  
[units: participants]
 
0= Asymptomatic and fully active     37  
1= Symptomatic; fully ambulatory     28  
Body Mass Index (BMI)  
[units: kg/m^2]
Median ( Full Range )
  27.8  
  ( 17.7 to 53.5 )  
Tumor location (Siewert Type) [1]
[units: participants]
 
I     36  
II     29  
Clinical T Stage  
[units: participants]
 
T2 = Tumor invades muscularis propria     7  
T3= Tumor invades adventitia     58  
Clinical N Stage  
[units: participants]
 
N0= No regional lymph node metastasis     13  
N1= Regional lymph node metastasis     52  
Clinical M Stage  
[units: participants]
 
M0= No distant metastasis     56  
M1a= Metastasis in celiac or cervical lymph nodes     9  
[1] Siewert Type I= Adenocarcinoma of the distal esophagus; Siewert Type II= Adenocarcinoma of the esophagogastric junction/real cardia



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Pathologic Complete Response Following Surgery   [ Time Frame: Post surgery ]

2.  Secondary:   Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)   [ Time Frame: Post surgery ]

3.  Secondary:   Percentage of Participants With 3-year Overall Survival   [ Time Frame: 3 years ]

4.  Secondary:   Percentage of Participants With 2-year Disease-free Survival   [ Time Frame: 2 years ]

5.  Secondary:   Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution   [ Time Frame: Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. A. Craig Lockhart
Organization: Washington University School of Medicine
phone: 314-454-8306
e-mail: alockhar@dom.wustl.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00757172     History of Changes
Other Study ID Numbers: CDR0000596674, ACOSOG-Z4051, CDR0000596674, NCI-2009-00346, U10CA076001
Study First Received: September 22, 2008
Results First Received: July 25, 2014
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration