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Trial record 6 of 7 for:    "Cloacogenic Carcinoma" | "Immunosuppressive Agents"

Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With 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: NCT00316888
Recruitment Status : Active, not recruiting
First Posted : April 21, 2006
Results First Posted : August 29, 2016
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anal Cancer
Interventions Biological: cetuximab
Drug: cisplatin
Drug: fluorouracil
Radiation: radiotherapy
Enrollment 63
Recruitment Details This study was activated on January 19, 2007, 28 patients were enrolled to arm I (closed to accrual on 11/3/2008) and 35 patients were enrolled to arm II (open to accrual on 8/18/2009).
Pre-assignment Details  
Arm/Group Title Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
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Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Period Title: Overall Study
Started 28 35
Eligible 28 35
Treated 28 [1] 34
Started Induction Chemotherapy 28 0 [2]
Started Chemo+Radiation+Cetuximab 27 [3] 34
Completed 22 27
Not Completed 6 8
Reason Not Completed
Adverse Event             4             5
Withdrawal by Subject             2             2
Not start protocol therapy             0             1
[1]
Received induction and/or chemo+radiation therapy
[2]
Induction chemotherapy was removed for patients on this arm
[3]
One patient did not start chemo+radiation therapy after completing induction therapy
Arm/Group Title Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009) Total
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Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Total of all reporting groups
Overall Number of Baseline Participants 27 34 61
Hide Baseline Analysis Population Description
all eligible and treated patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 34 participants 61 participants
56
(42 to 77)
56
(37 to 78)
56
(37 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 34 participants 61 participants
Female
21
  77.8%
28
  82.4%
49
  80.3%
Male
6
  22.2%
6
  17.6%
12
  19.7%
1.Primary Outcome
Title Local Failure Rate at 3 Years
Hide Description Local failure was defined as progression/relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes after completion of protocol therapy, or progression during protocol therapy. Lost to follow-up and death (regardless of cause of death) prior to 3 years were also considered as local failures. For the calculation of local failure rate at 3 years, patients were classified into two groups (ie, coded as binary variable): failure (patients with local failure events prior to 3 years) vs. no failure (patients who still alive and had no local failure at 3 years). The binomial proportion and its exact two-sided 80% confidence interval (CI) were used to estimate it.
Time Frame assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3
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eligible and treated patients
Arm/Group Title Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
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Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Overall Number of Participants Analyzed 27 34
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: proportion of participants
0.259
(0.150 to 0.397)
0.353
(0.243 to 0.477)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Closed to Accrual as of 11/3/2008)
Comments Null hypothesis is that the local failure rate at 3 years is no more than 35%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments [Not Specified]
Method one sample binomial test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm II (Open to Accrual on 8/18/2009)
Comments The null hypothesis is that the local failure rate at 3 years is no more than 35%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.592
Comments [Not Specified]
Method one sample binomial test
Comments [Not Specified]
2.Secondary Outcome
Title 3-year Overall Survival Rate
Hide Description Overall survival (OS) is defined as time from registration to death from any cause. Patients alive are censored at the last contact date. Kaplan-Meier method was used to estimate the 3-year OS rate.
Time Frame assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3
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Hide Analysis Population Description
eligible and treated patients
Arm/Group Title Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
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Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Overall Number of Participants Analyzed 27 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.887
(0.690 to 0.962)
0.789
(0.606 to 0.893)
3.Secondary Outcome
Title 3-year Progression-free Survival Rate
Hide Description Progression-free survival (PFS) was defined as time from registration to disease progression, relapse or death (whichever occurred first), censoring cases without PFS events at the date of last disease assessment documenting the patient was free of progression/relapse. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the 3-year PFS rate.
Time Frame assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3
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Hide Analysis Population Description
eligible and treated patients
Arm/Group Title Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
Hide Arm/Group Description:

Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Overall Number of Participants Analyzed 27 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.809
(0.600 to 0.916)
0.616
(0.432 to 0.756)
4.Secondary Outcome
Title Objective Response Rate
Hide Description Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).
Time Frame Tumor assessments were made at baseline, within 4 weeks of the completion of protocol treatment, then every 6 months if patient was 1-4 years from registration, yearly if patient was 5-10 years from registration until progression/relapse using the RECIST
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Hide Analysis Population Description
eligible and treated patients
Arm/Group Title Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
Hide Arm/Group Description:

Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Overall Number of Participants Analyzed 27 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.630
(0.424 to 0.806)
0.647
(0.465 to 0.802)
5.Secondary Outcome
Title 3-year Colostomy-free Survival Rate
Hide Description Colostomy-free survival was defined as time from registration until time of colostomy or death without colostomy, censoring cases without colostomy at the data of last disease assessment documenting the patient was free of colostomy. Kaplan-Meier method was used to estimate the 3-year colostomy-free survival rate.
Time Frame assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3
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Hide Analysis Population Description
eligible and treated patients who did not have permanent colostomy at study entry
Arm/Group Title Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
Hide Arm/Group Description:

Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Overall Number of Participants Analyzed 27 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.849
(0.645 to 0.940)
0.657
(0.446 to 0.804)
Time Frame Adverse events were assessed every cycle (1 cycle=28 days) while on treatment and for 30 days after the end of treatment. After discontinuation of treatment, severe (Grade ≥ 3) long term toxicity that had not been previously reported were collected via the Long term follow-up form using the following schedule: every 3 months within 2 years of registration, then every 6 months in years 2-5, annually afterward until year 10.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
Hide Arm/Group Description

Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

cisplatin: Given IV

fluorouracil: Given IV

radiation therapy: Given once daily 5 days a week for 5 weeks

All-Cause Mortality
Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
Affected / at Risk (%) Affected / at Risk (%)
Total   26/28 (92.86%)   29/34 (85.29%) 
Blood and lymphatic system disorders     
Anemia  1  2/28 (7.14%)  5/34 (14.71%) 
Febrile neutropenia  1  0/28 (0.00%)  1/34 (2.94%) 
Cardiac disorders     
Left ventricular systolic dysfunction  1  0/28 (0.00%)  1/34 (2.94%) 
Ear and labyrinth disorders     
Tinnitus  1  1/28 (3.57%)  0/34 (0.00%) 
Gastrointestinal disorders     
Diarrhea w/o prior colostomy  1  15/28 (53.57%)  23/34 (67.65%) 
Dry mouth  1  1/28 (3.57%)  0/34 (0.00%) 
Malabsorption  1  1/28 (3.57%)  0/34 (0.00%) 
Muco/stomatitis by exam, oral cavity  1  1/28 (3.57%)  3/34 (8.82%) 
Muco/stomatitis (symptom) esophagus  1  0/28 (0.00%)  1/34 (2.94%) 
Muco/stomatitis (symptom) oral cavity  1  2/28 (7.14%)  1/34 (2.94%) 
Muco/stomatitis (symptom) rectum  1  1/28 (3.57%)  0/34 (0.00%) 
Nausea  1  7/28 (25.00%)  11/34 (32.35%) 
Vomiting  1  2/28 (7.14%)  5/34 (14.71%) 
Rectum, hemorrhage  1  1/28 (3.57%)  0/34 (0.00%) 
Abdomen, pain  1  1/28 (3.57%)  3/34 (8.82%) 
Anus, pain  1  1/28 (3.57%)  2/34 (5.88%) 
Rectum, pain  1  2/28 (7.14%)  1/34 (2.94%) 
General disorders     
Fatigue  1  6/28 (21.43%)  7/34 (20.59%) 
Immune system disorders     
Allergic reaction  1  0/28 (0.00%)  1/34 (2.94%) 
Infections and infestations     
Infection w/ gr3-4 neut, lung  1  0/28 (0.00%)  1/34 (2.94%) 
Infection Gr0-2 neut, bladder  1  1/28 (3.57%)  2/34 (5.88%) 
Infection Gr0-2 neut, rectum  1  1/28 (3.57%)  0/34 (0.00%) 
Infection Gr0-2 neut, blood  1  0/28 (0.00%)  1/34 (2.94%) 
Infection w/ unk ANC blood  1  1/28 (3.57%)  1/34 (2.94%) 
Injury, poisoning and procedural complications     
Chemoradiation dermatitis  1  4/28 (14.29%)  0/34 (0.00%) 
Radiation dermatitis  1  3/28 (10.71%)  1/34 (2.94%) 
Investigations     
Leukocytes decreased  1  7/28 (25.00%)  14/34 (41.18%) 
Lymphopenia  1  3/28 (10.71%)  6/34 (17.65%) 
Neutrophils decreased  1  6/28 (21.43%)  17/34 (50.00%) 
Platelets decreased  1  2/28 (7.14%)  4/34 (11.76%) 
Weight loss  1  1/28 (3.57%)  1/34 (2.94%) 
INR increased  1  1/28 (3.57%)  0/34 (0.00%) 
Activated partial thromboplastin time prolonged  1  1/28 (3.57%)  0/34 (0.00%) 
Creatinine increased  1  0/28 (0.00%)  1/34 (2.94%) 
Metabolism and nutrition disorders     
Anorexia  1  3/28 (10.71%)  7/34 (20.59%) 
Dehydration  1  9/28 (32.14%)  11/34 (32.35%) 
Acidosis  1  1/28 (3.57%)  1/34 (2.94%) 
Hypoalbuminemia  1  1/28 (3.57%)  3/34 (8.82%) 
Hypocalcemia  1  0/28 (0.00%)  2/34 (5.88%) 
Hyperglycemia  1  0/28 (0.00%)  1/34 (2.94%) 
Hypomagnesemia  1  2/28 (7.14%)  1/34 (2.94%) 
Hypophosphatemia  1  1/28 (3.57%)  3/34 (8.82%) 
Hypokalemia  1  4/28 (14.29%)  8/34 (23.53%) 
Hyponatremia  1  0/28 (0.00%)  2/34 (5.88%) 
Musculoskeletal and connective tissue disorders     
Nonneuropathic generalized weakness  1  1/28 (3.57%)  0/34 (0.00%) 
Osteoporosis  1  1/28 (3.57%)  0/34 (0.00%) 
Back, pain  1  1/28 (3.57%)  0/34 (0.00%) 
Nervous system disorders     
Ataxia  1  0/28 (0.00%)  1/34 (2.94%) 
Dizziness  1  1/28 (3.57%)  0/34 (0.00%) 
Head/headache  1  1/28 (3.57%)  1/34 (2.94%) 
Renal and urinary disorders     
Bladder, pain  1  0/28 (0.00%)  1/34 (2.94%) 
Cystitis  1  0/28 (0.00%)  1/34 (2.94%) 
Renal failure  1  1/28 (3.57%)  1/34 (2.94%) 
Renal/GU-other  1  0/28 (0.00%)  1/34 (2.94%) 
Reproductive system and breast disorders     
Scrotum, pain  1  0/28 (0.00%)  1/34 (2.94%) 
Vaginal mucositis  1  0/28 (0.00%)  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders     
Muco/stomatitis (symptom) pharynx  1  1/28 (3.57%)  0/34 (0.00%) 
Dyspnea  1  0/28 (0.00%)  1/34 (2.94%) 
Pneumonitis/pulmonary infiltrates  1  0/28 (0.00%)  1/34 (2.94%) 
Pulmonary/Upper Respiratory-other  1  1/28 (3.57%)  0/34 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash/desquamation  1  0/28 (0.00%)  1/34 (2.94%) 
Rash: acne/acneiform  1  0/28 (0.00%)  2/34 (5.88%) 
Ulceration  1  1/28 (3.57%)  1/34 (2.94%) 
Skin, pain  1  2/28 (7.14%)  0/34 (0.00%) 
Vascular disorders     
Thrombosis/thrombus/embolism  1  1/28 (3.57%)  2/34 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Closed to Accrual as of 11/3/2008) Arm II (Open to Accrual on 8/18/2009)
Affected / at Risk (%) Affected / at Risk (%)
Total   28/28 (100.00%)   34/34 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  11/28 (39.29%)  12/34 (35.29%) 
Cardiac disorders     
Sinus tachycardia  1  0/28 (0.00%)  2/34 (5.88%) 
Ear and labyrinth disorders     
Tinnitus  1  3/28 (10.71%)  1/34 (2.94%) 
Eye disorders     
Vision-blurred  1  2/28 (7.14%)  0/34 (0.00%) 
Tearing  1  2/28 (7.14%)  0/34 (0.00%) 
Gastrointestinal disorders     
Constipation  1  7/28 (25.00%)  7/34 (20.59%) 
Diarrhea w/o prior colostomy  1  15/28 (53.57%)  9/34 (26.47%) 
Dysphagia  1  2/28 (7.14%)  0/34 (0.00%) 
Dyspepsia  1  5/28 (17.86%)  0/34 (0.00%) 
Muco/stomatitis by exam, oral cavity  1  12/28 (42.86%)  9/34 (26.47%) 
Muco/stomatitis (symptom) oral cavity  1  9/28 (32.14%)  10/34 (29.41%) 
Nausea  1  23/28 (82.14%)  19/34 (55.88%) 
Proctitis  1  0/28 (0.00%)  2/34 (5.88%) 
Vomiting  1  17/28 (60.71%)  13/34 (38.24%) 
Rectum, hemorrhage  1  2/28 (7.14%)  2/34 (5.88%) 
Abdomen, pain  1  3/28 (10.71%)  4/34 (11.76%) 
Anus, pain  1  1/28 (3.57%)  2/34 (5.88%) 
Rectum, pain  1  7/28 (25.00%)  4/34 (11.76%) 
General disorders     
Fatigue  1  23/28 (82.14%)  23/34 (67.65%) 
Fever w/o neutropenia  1  4/28 (14.29%)  6/34 (17.65%) 
Edema limb  1  2/28 (7.14%)  0/34 (0.00%) 
Injury, poisoning and procedural complications     
Burn  1  4/28 (14.29%)  5/34 (14.71%) 
Chemoradiation dermatitis  1  2/28 (7.14%)  1/34 (2.94%) 
Radiation dermatitis  1  1/28 (3.57%)  4/34 (11.76%) 
Investigations     
Leukocytes decreased  1  15/28 (53.57%)  11/34 (32.35%) 
Lymphopenia  1  2/28 (7.14%)  1/34 (2.94%) 
Neutrophils decreased  1  11/28 (39.29%)  7/34 (20.59%) 
Platelets decreased  1  11/28 (39.29%)  14/34 (41.18%) 
Weight loss  1  11/28 (39.29%)  25/34 (73.53%) 
Alkaline phosphatase increased  1  1/28 (3.57%)  4/34 (11.76%) 
Alanine aminotransferase increased  1  1/28 (3.57%)  2/34 (5.88%) 
Aspartate aminotransferase increased  1  1/28 (3.57%)  2/34 (5.88%) 
Creatinine increased  1  4/28 (14.29%)  3/34 (8.82%) 
Metabolism and nutrition disorders     
Anorexia  1  15/28 (53.57%)  13/34 (38.24%) 
Dehydration  1  2/28 (7.14%)  5/34 (14.71%) 
Hypoalbuminemia  1  4/28 (14.29%)  9/34 (26.47%) 
Hypocalcemia  1  4/28 (14.29%)  8/34 (23.53%) 
Hyperglycemia  1  2/28 (7.14%)  3/34 (8.82%) 
Hypomagnesemia  1  17/28 (60.71%)  21/34 (61.76%) 
Hypokalemia  1  4/28 (14.29%)  5/34 (14.71%) 
Hyponatremia  1  3/28 (10.71%)  7/34 (20.59%) 
Musculoskeletal and connective tissue disorders     
Nonneuropathic generalized weakness  1  1/28 (3.57%)  2/34 (5.88%) 
Nervous system disorders     
Taste disturbance  1  8/28 (28.57%)  5/34 (14.71%) 
Dizziness  1  3/28 (10.71%)  1/34 (2.94%) 
Neuropathy-sensory  1  5/28 (17.86%)  3/34 (8.82%) 
Head/headache  1  7/28 (25.00%)  2/34 (5.88%) 
Psychiatric disorders     
Insomnia  1  1/28 (3.57%)  4/34 (11.76%) 
Anxiety  1  0/28 (0.00%)  2/34 (5.88%) 
Renal and urinary disorders     
Urethra, pain  1  2/28 (7.14%)  0/34 (0.00%) 
Reproductive system and breast disorders     
Vaginitis (not due to infection)  1  0/28 (0.00%)  2/34 (5.88%) 
Respiratory, thoracic and mediastinal disorders     
Muco/stomatitis by exam, pharynx  1  1/28 (3.57%)  2/34 (5.88%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  9/28 (32.14%)  7/34 (20.59%) 
Alopecia  1  9/28 (32.14%)  5/34 (14.71%) 
Pruritus/itching  1  3/28 (10.71%)  2/34 (5.88%) 
Rash/desquamation  1  2/28 (7.14%)  2/34 (5.88%) 
Rash: acne/acneiform  1  15/28 (53.57%)  19/34 (55.88%) 
Hand-foot reaction  1  2/28 (7.14%)  0/34 (0.00%) 
Ulceration  1  4/28 (14.29%)  2/34 (5.88%) 
Vascular disorders     
Hypertension  1  0/28 (0.00%)  3/34 (8.82%) 
Hypotension  1  2/28 (7.14%)  2/34 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: ECOG-ACRIN statistician
Organization: ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Publications:
Garg M, Lee JY, Kachnic LA, et al.: Phase II trials of cetuximab (CX) plus cisplatin (CDDP), 5-fluorouracil (5-FU) and radiation (RT) in immunocompetent (ECOG 3205) and HIV-positive (AMC045) patients with squamous cell carcinoma of the anal canal (SCAC): safety and preliminary efficacy results. [Abstract] J Clin Oncol 30 (Suppl 15): A-4030, 2012.
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier: NCT00316888     History of Changes
Other Study ID Numbers: E3205
E3205 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA023318 ( U.S. NIH Grant/Contract )
CDR0000470269 ( Registry Identifier: Clinical Data Repository )
First Submitted: April 19, 2006
First Posted: April 21, 2006
Results First Submitted: July 18, 2016
Results First Posted: August 29, 2016
Last Update Posted: January 11, 2019