Trial Outcomes & Findings for Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer (NCT NCT00444678)
NCT ID: NCT00444678
Last Updated: 2020-04-03
Results Overview
The tumor response rate (RR) will be defined as the total number of subjects whose best response is partial response (PR) or complete response (CR) during the first six months of treatment, divided by the number of subjects.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
6 months since the start of treatment
Results posted on
2020-04-03
Participant Flow
Participant milestones
| Measure |
Cetuximab, Capecitabine and Oxaliplatin
Cetuximab: 500 mg/m2, IV every two weeks
Oxaliplatin: 85 mg/m2, IV, q 2 weeks
Capecitabine: 2500 mg, po bid x 7 days every two weeks
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Cetuximab, Capecitabine and Oxaliplatin
Cetuximab: 500 mg/m2, IV every two weeks
Oxaliplatin: 85 mg/m2, IV, q 2 weeks
Capecitabine: 2500 mg, po bid x 7 days every two weeks
|
|---|---|
|
Overall Study
Toxicity
|
11
|
|
Overall Study
Disease Progression
|
12
|
|
Overall Study
Death
|
3
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab, Capecitabine and Oxaliplatin
n=36 Participants
Cetuximab: 500 mg/m2, IV every two weeks
Oxaliplatin: 85 mg/m2, IV, q 2 weeks
Capecitabine: 2500 mg, po bid x 7 days every two weeks
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months since the start of treatmentThe tumor response rate (RR) will be defined as the total number of subjects whose best response is partial response (PR) or complete response (CR) during the first six months of treatment, divided by the number of subjects.
Outcome measures
| Measure |
Cetuximab, Capecitabine and Oxaliplatin
n=36 Participants
Cetuximab: 500 mg/m2, IV every two weeks
Oxaliplatin: 85 mg/m2, IV, q 2 weeks
Capecitabine: 2500 mg, po bid x 7 days every two weeks
|
|---|---|
|
Response Rate for the Combination Treatment
|
21 Participants
|
SECONDARY outcome
Timeframe: 1 year since the first treatment and every year after for up to 10 years\# of subjects who experienced \>= grade 1 adverse event that is positively related to treatment.
Outcome measures
| Measure |
Cetuximab, Capecitabine and Oxaliplatin
n=36 Participants
Cetuximab: 500 mg/m2, IV every two weeks
Oxaliplatin: 85 mg/m2, IV, q 2 weeks
Capecitabine: 2500 mg, po bid x 7 days every two weeks
|
|---|---|
|
Toxicity Rates
|
36 Participants
|
SECONDARY outcome
Timeframe: 6 months since the start of treatment and every 3 months after treatment for up to 10 yearsTime to Treatment Failure (progression or death) will be defined as the time from the first day of treatment until the date Progressive Disease (PD) or death is first reported. Subjects who die without a reported prior progression will be considered to have progressed on the day of their death. Subjects who did not progress will be censored at the day of their last tumor assessment.
Outcome measures
| Measure |
Cetuximab, Capecitabine and Oxaliplatin
n=36 Participants
Cetuximab: 500 mg/m2, IV every two weeks
Oxaliplatin: 85 mg/m2, IV, q 2 weeks
Capecitabine: 2500 mg, po bid x 7 days every two weeks
|
|---|---|
|
Time to Progression
|
275 Days
Interval 43.0 to 2822.0
|
SECONDARY outcome
Timeframe: 6 months since the start of treatment and every 3 months after treatment for up to 10 yearsSurvival will be defined as the number of days from the first day of therapy to the date of death. If the subject is lost to follow-up, survival will be censored on the last date the subject was known to be alive.
Outcome measures
| Measure |
Cetuximab, Capecitabine and Oxaliplatin
n=36 Participants
Cetuximab: 500 mg/m2, IV every two weeks
Oxaliplatin: 85 mg/m2, IV, q 2 weeks
Capecitabine: 2500 mg, po bid x 7 days every two weeks
|
|---|---|
|
Survival
|
417 Days
Interval 43.0 to 4166.0
|
Adverse Events
Cetuximab, Capecitabine and Oxaliplatin
Serious events: 14 serious events
Other events: 26 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cetuximab, Capecitabine and Oxaliplatin
n=36 participants at risk
Cetuximab: 500 mg/m2, IV every two weeks
Oxaliplatin: 85 mg/m2, IV, q 2 weeks
Capecitabine: 2500 mg, po bid x 7 days every two weeks
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
diarrhea
|
11.1%
4/36 • Number of events 4 • 3 years
|
|
Cardiac disorders
Vasovagal Episode
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Cardiac disorders
hypotension
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
dehydration
|
8.3%
3/36 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
5.6%
2/36 • Number of events 2 • 3 years
|
|
Nervous system disorders
seizure
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • Number of events 2 • 3 years
|
|
Cardiac disorders
Thrombosis
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Cardiac disorders
Death
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Obstruction - Gi
|
8.3%
3/36 • Number of events 3 • 3 years
|
|
Blood and lymphatic system disorders
Hemorrage/ Bleeding
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
General disorders
fatigue
|
8.3%
3/36 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
colitis
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Immune system disorders
Infection
|
5.6%
2/36 • Number of events 2 • 3 years
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Infections and infestations
Sepsis
|
5.6%
2/36 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Fistula
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
2/36 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Anorexia
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Weight loss
|
2.8%
1/36 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Disease progression on study
|
2.8%
1/36 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Cetuximab, Capecitabine and Oxaliplatin
n=36 participants at risk
Cetuximab: 500 mg/m2, IV every two weeks
Oxaliplatin: 85 mg/m2, IV, q 2 weeks
Capecitabine: 2500 mg, po bid x 7 days every two weeks
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
33.3%
12/36 • 3 years
|
|
General disorders
Alkaline phosphatase
|
8.3%
3/36 • 3 years
|
|
General disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.8%
1/36 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.8%
1/36 • 3 years
|
|
Psychiatric disorders
Anorexia
|
50.0%
18/36 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
2.8%
1/36 • 3 years
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
2.8%
1/36 • 3 years
|
|
Renal and urinary disorders
Bicarbonate
|
5.6%
2/36 • 3 years
|
|
Hepatobiliary disorders
bilirubin
|
2.8%
1/36 • 3 years
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
2.8%
1/36 • 3 years
|
|
Blood and lymphatic system disorders
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
2.8%
1/36 • 3 years
|
|
Cardiac disorders
Cardiovascular/Arrhythmia-Other
|
5.6%
2/36 • 3 years
|
|
Gastrointestinal disorders
Colitis
|
5.6%
2/36 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
30.6%
11/36 • 3 years
|
|
General disorders
Constitutional Symptoms-Other
|
5.6%
2/36 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
2/36 • 3 years
|
|
General disorders
Dehydration
|
11.1%
4/36 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
33.3%
12/36 • 3 years
|
|
Gastrointestinal disorders
Diarrhea - patients with a colostomy
|
8.3%
3/36 • 3 years
|
|
Gastrointestinal disorders
Diarrhea - patients without colostomy
|
55.6%
20/36 • 3 years
|
|
Nervous system disorders
Dizziness/lightheadedness
|
13.9%
5/36 • 3 years
|
|
Eye disorders
Dry Eye
|
2.8%
1/36 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
11.1%
4/36 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
13.9%
5/36 • 3 years
|
|
General disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
5.6%
2/36 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
13.9%
5/36 • 3 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
2.8%
1/36 • 3 years
|
|
Blood and lymphatic system disorders
Edema
|
8.3%
3/36 • 3 years
|
|
Reproductive system and breast disorders
Erectile impotence
|
2.8%
1/36 • 3 years
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
55.6%
20/36 • 3 years
|
|
Immune system disorders
Febrile neutropenia
|
2.8%
1/36 • 3 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
13.9%
5/36 • 3 years
|
|
Gastrointestinal disorders
Fistula-intestinal
|
2.8%
1/36 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
13.9%
5/36 • 3 years
|
|
General disorders
Flushing
|
2.8%
1/36 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
16.7%
6/36 • 3 years
|
|
General disorders
Nausea
|
72.2%
26/36 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
69.4%
25/36 • 3 years
|
|
Nervous system disorders
Neuropathy-sensory
|
61.1%
22/36 • 3 years
|
|
General disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
47.2%
17/36 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place