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

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ClinicalTrials.gov Identifier: NCT00324415
Recruitment Status : Completed
First Posted : May 11, 2006
Results First Posted : September 17, 2015
Last Update Posted : June 5, 2018
Sponsor:
Collaborators:
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
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description Combined modality therapy consists of cisplatin, 5-flourouracil, and irradiation plus cetuximab
Period Title: Overall Study
Started 45
Completed 45
Not Completed 0
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
48.4  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
4
   8.9%
Male
41
  91.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Hispanic or Latino
7
  15.6%
Not Hispanic or Latino
37
  82.2%
Unknown or Not Reported
1
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
1.Primary Outcome
Title Local Failure Rate at 3 Years
Hide Description Patients will be classified into two groups for purposes of primary endpoint analysis: failure or no failure at 3 years (in the primary analysis, patients lost to follow-up prior to 3 years will be considered failures). For the secondary endpoint of objective response, patients will be classified as responders
Time Frame 3 years following treatment discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
23
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival at 1 year is the percentage of patients who are alive and have not experienced progressive disease, defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.3
(72.1 to 94.5)
3.Secondary Outcome
Title Relapse-free Survival
Hide Description Percentage of participants who are alive and have not experienced progressive disease and have not relapsed
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.1
(67.8 to 91.6)
4.Secondary Outcome
Title Colostomy-free Survival at 1 Year
Hide Description Percentage of participants who are alive and have not had a colostomy
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.4
(78.3 to 97.5)
5.Secondary Outcome
Title Overall Survival
Hide Description Percentage of participants who are alive at one year
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.8
(79.4 to 97.7)
6.Secondary Outcome
Title Quality of Life
Hide Description EORTC QLQ-C30 Global Score at 1 year. The EORTC QLQ-C30 is a validated questionnaire that evaluates quality of life. The global score is an overall score for quality of life that ranges from 0 to 100. Higher scores indicate between quality of life
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number of participants for whom quality of life questionnaires were completed at one year.
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
78.9  (24.0)
7.Secondary Outcome
Title Toxicity
Hide Description Delayed toxicities are defined as toxicities that occur over 90 days following treatment completion
Time Frame 90 days following treatment discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: events
5
8.Secondary Outcome
Title Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment
Hide Description Change in absolute CD4 counts from start of treatment to 1 year after completion of study treatment
Time Frame 1 year following treatment discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number for whom absolute CD4 count data were available at baseline at at 1 year after study completion
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab
Overall Number of Participants Analyzed 38
Median (Full Range)
Unit of Measure: cells/mm3
102
(-403 to 669)
9.Secondary Outcome
Title Incidence of Opportunistic Illnesses
Hide Description Incidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment
Time Frame 1 year following treatment discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
4
10.Secondary Outcome
Title Anogenital Human Papilloma Virus (HPV) Infection and Anal Cytology
Hide Description [Not Specified]
Time Frame 6 months following treatment discontinuation
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Objective Response Rate (Complete and Partial)
Hide Description Number of participants with complete and partial responses based on the RECIST criteria
Time Frame 3 years following treatment discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description:
cisplatin, 5-flourouruacil, and irradiation plus cetuximab
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
30
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combined Modality Therapy
Hide Arm/Group Description cisplatin, 5-flourouruacil, and irradiation plus cetuximab
All-Cause Mortality
Combined Modality Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Combined Modality Therapy
Affected / at Risk (%) # Events
Total   27/45 (60.00%)    
Blood and lymphatic system disorders   
Anemia * 1  2/45 (4.44%)  2
Febrile neutropenia * 1  3/45 (6.67%)  3
Gastrointestinal disorders   
Anal fistula * 1  2/45 (4.44%)  2
Anal mucositis * 1  1/45 (2.22%)  1
Anal pain * 1  3/45 (6.67%)  3
Diarrhea * 1  8/45 (17.78%)  9
Duodenal hemorrhage * 1  1/45 (2.22%)  1
Enterocolitis * 1  1/45 (2.22%)  1
Esophagitis * 1  1/45 (2.22%)  1
Gastritis * 1  1/45 (2.22%)  1
Oral mucositis * 1  1/45 (2.22%)  1
Nausea * 1  3/45 (6.67%)  3
Vomiting * 1  2/45 (4.44%)  2
melena * 1  1/45 (2.22%)  1
General disorders   
death NOS * 1  3/45 (6.67%)  3
Fatigue * 1  1/45 (2.22%)  1
Fever * 1  2/45 (4.44%)  2
Pain * 1  1/45 (2.22%)  1
Infections and infestations   
Anorectal infection * 1  3/45 (6.67%)  3
Lung infection * 1  1/45 (2.22%)  1
Meningitis * 1  1/45 (2.22%)  1
Scrotal infection * 1  1/45 (2.22%)  1
Wound infection * 1  1/45 (2.22%)  1
Infection with grade 3 or 4 neutrophils * 1  2/45 (4.44%)  2
Lung pneumonia * 1  1/45 (2.22%)  1
Toxoplasmosis with Hydrocephalus * 1  1/45 (2.22%)  1
Cellulitis * 1  1/45 (2.22%)  1
Injury, poisoning and procedural complications   
Fracture * 1  1/45 (2.22%)  1
Radiation reaction (dermatologic) * 1  1/45 (2.22%)  1
Investigations   
Creatinine increased * 1  1/45 (2.22%)  1
Neutrophil count decreased * 1  3/45 (6.67%)  3
Platelet count decreased * 1  3/45 (6.67%)  3
White blood count decreased * 1  3/45 (6.67%)  3
Metabolism and nutrition disorders   
Acidosis * 1  1/45 (2.22%)  1
Anorexia * 1  1/45 (2.22%)  1
Dehydration * 1  9/45 (20.00%)  9
Hypokalemia * 1  9/45 (20.00%)  9
Pain in extremity * 1  1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness * 1  1/45 (2.22%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Treatment related secondary malignancy * 1  1/45 (2.22%)  1
Nervous system disorders   
Cognitive disturbance * 1  2/45 (4.44%)  2
Headache * 1  1/45 (2.22%)  1
Syncope * 1  1/45 (2.22%)  1
Renal and urinary disorders   
Acute kidney injury * 1  1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis * 1  1/45 (2.22%)  1
Respiratory arrest * 1  1/45 (2.22%)  1
Skin and subcutaneous tissue disorders   
Erythema multiforme * 1  1/45 (2.22%)  1
Other skin disorder * 1  2/45 (4.44%)  2
Vascular disorders   
Hypotension * 1  1/45 (2.22%)  1
Thromboembolic event * 1  1/45 (2.22%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combined Modality Therapy
Affected / at Risk (%) # Events
Total   41/45 (91.11%)    
Blood and lymphatic system disorders   
Anemia * 1  14/45 (31.11%)  26
Other blood and lymphatic disorders * 1  5/45 (11.11%)  7
Gastrointestinal disorders   
Abdominal pain * 1  3/45 (6.67%)  3
Constipation * 1  7/45 (15.56%)  7
Anal pain * 1  10/45 (22.22%)  14
Diarrhea * 1  22/45 (48.89%)  38
Other GI disorders * 1  9/45 (20.00%)  21
Oral mucositis * 1  10/45 (22.22%)  23
Nausea * 1  12/45 (26.67%)  18
Proctitis * 1  5/45 (11.11%)  7
Rectal pain * 1  3/45 (6.67%)  4
Vomiting * 1  7/45 (15.56%)  8
General disorders   
Fatigue * 1  17/45 (37.78%)  18
Fever * 1  5/45 (11.11%)  5
Other general disorders * 1  6/45 (13.33%)  7
Pain * 1  3/45 (6.67%)  4
Infections and infestations   
Anorectal infection * 1  3/45 (6.67%)  3
Other infections * 1  4/45 (8.89%)  6
Injury, poisoning and procedural complications   
Dermatitis radiation * 1  3/45 (6.67%)  3
Radiation recall reaction (dermatologic) * 1  11/45 (24.44%)  16
Aspartate aminotransferase increased * 1  4/45 (8.89%)  4
Investigations   
Alanine aminotransferase increased * 1  4/45 (8.89%)  4
Blood bilirubin increased * 1  3/45 (6.67%)  6
Neutrophil count decreased * 1  10/45 (22.22%)  18
Platelet count decreased * 1  13/45 (28.89%)  17
Weight loss * 1  11/45 (24.44%)  12
White blood cell decreased * 1  11/45 (24.44%)  34
Metabolism and nutrition disorders   
Anorexia * 1  9/45 (20.00%)  11
Dehydration * 1  10/45 (22.22%)  11
hypoalbuminemia * 1  4/45 (8.89%)  5
Hypocalcemia * 1  7/45 (15.56%)  9
Hypokalemia * 1  10/45 (22.22%)  17
Hypomagnesia * 1  5/45 (11.11%)  5
Hyponatremia * 1  7/45 (15.56%)  11
Musculoskeletal and connective tissue disorders   
Muscle weakness * 1  3/45 (6.67%)  3
Nervous system disorders   
Anxiety * 1  3/45 (6.67%)  3
Depression * 1  4/45 (8.89%)  4
Insomnia * 1  4/45 (8.89%)  4
Renal and urinary disorders   
Other renal and urinary disorders * 1  3/45 (6.67%)  4
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/45 (6.67%)  3
Dyspnea * 1  6/45 (13.33%)  6
Skin and subcutaneous tissue disorders   
Alopecia * 1  5/45 (11.11%)  5
Dry skin * 1  4/45 (8.89%)  4
Erythema multiforme * 1  3/45 (6.67%)  3
Rash acneiform * 1  12/45 (26.67%)  15
Other skin disorders * 1  12/45 (26.67%)  20
Skin ulceration * 1  3/45 (6.67%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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
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: June 5, 2018