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Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00324415
Recruitment Status : Completed
First Posted : May 11, 2006
Results First Posted : September 17, 2015
Last Update Posted : March 6, 2018
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Anal Cancer
Interventions: Biological: cetuximab
Drug: cisplatin
Drug: fluorouracil
Radiation: radiation therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Combined Modality Therapy Combined modality therapy consists of cisplatin, 5-flourouracil, and irradiation plus cetuximab

Participant Flow:   Overall Study
    Combined Modality Therapy

  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.
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Reporting Groups
Combined Modality Therapy cisplatin, 5-flourouruacil, and irradiation plus cetuximab.

Baseline Measures
   Combined Modality Therapy 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 48.4  (6.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      4   8.9% 
Male      41  91.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      7  15.6% 
Not Hispanic or Latino      37  82.2% 
Unknown or Not Reported      1   2.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
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      13  28.9% 
White      28  62.2% 
More than one race      0   0.0% 
Unknown or Not Reported      4   8.9% 
Region of Enrollment 
[Units: Participants]
United States   45 

  Outcome Measures

1.  Primary:   Local Failure Rate at 3 Years   [ Time Frame: 3 years following treatment discontinuation ]

2.  Secondary:   Progression-free Survival   [ Time Frame: 1 year ]

3.  Secondary:   Relapse-free Survival   [ Time Frame: 1 year ]

4.  Secondary:   Colostomy-free Survival at 1 Year   [ Time Frame: 1 year ]

5.  Secondary:   Overall Survival   [ Time Frame: 1 year ]

6.  Secondary:   Quality of Life   [ Time Frame: 1 year ]

7.  Secondary:   Toxicity   [ Time Frame: 90 days following treatment discontinuation ]

8.  Secondary:   Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment   [ Time Frame: 1 year following treatment discontinuation ]

9.  Secondary:   Incidence of Opportunistic Illnesses   [ Time Frame: 1 year following treatment discontinuation ]

10.  Secondary:   Objective Response Rate (Complete and Partial)   [ Time Frame: 3 years following treatment discontinuation ]

11.  Secondary:   Anogenital Human Papilloma Virus (HPV) Infection and Anal Cytology   [ Time Frame: 6 months following treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  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
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  More Information

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: Director, AMC Statistical Center
Organization: AMC
phone: 501-526-6712
e-mail: jylee@uams.edu

Publications of Results:

Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00324415     History of Changes
Other Study ID Numbers: AMC-045
U01CA070019 ( U.S. NIH Grant/Contract )
CDR0000440065 ( Other Identifier: NCI )
First Submitted: May 10, 2006
First Posted: May 11, 2006
Results First Submitted: July 22, 2015
Results First Posted: September 17, 2015
Last Update Posted: March 6, 2018