Cetuximab for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Intermountain Medical Center, Salt Lake City, UT
Colorectal Cancer+1 More
Cetuximab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called cetuximab can help treat people with colorectal cancer.

See full description

Eligible Conditions

  • Colorectal Cancer
  • Colorectal Carcinoma (CRC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Colorectal Cancer

Study Objectives

This trial is evaluating whether Cetuximab will improve 1 primary outcome and 1 secondary outcome in patients with Colorectal Cancer. Measurement will happen over the course of PFS will be measured from the date of first dose of study drug until first documented clinical or radiographic evidence of disease progression by RECIST 1.1, clinical progression, start of new therapy or death. Estimated assessment at 6 months..

Year 5
Overall survival (OS).
Month 6
Progression free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Colorectal Cancer

Side Effects for

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
Leucopenia
43%
Weight Decreased
43%
Nausea
40%
Rash
35%
Hypomagnesaemia
34%
Hypokalemia
32%
Constipation
31%
Neutropenia
28%
Vomiting
28%
Decreased Appetite
26%
Pyrexia
22%
Hemoglobin Decreased
19%
Hyponatremia
19%
Acne
19%
Diarrhea
18%
Stomatitis
18%
Fatigue
15%
Pruritus
15%
Mucosal Inflammation
13%
Neutrophil Count Decreased
13%
Mouth Ulceration
12%
Thrombocytopenia
10%
Asthenia
10%
Insomnia
10%
Cough
9%
White Blood Cell Count Decreased
9%
Dizziness
9%
Abdominal Pain Upper
7%
Aspartate Aminotransferase Increased
7%
Paronychia
7%
Hypochloremia
7%
Weight Increased
7%
Hypocalcaemia
7%
Dermatitis Acneiform
7%
Oral Pain
6%
Headache
6%
Neck pain
6%
Dyspnoea
6%
Anaphylactic reaction
3%
Pulmonary embolism
1%
Toxic encephalopathy
1%
Myocardial infarction
1%
Staphylococcal skin infection
1%
Microcytic anemia
1%
Electrolyte imbalance
1%
Tumor hemorrhage
1%
Pneumonia
1%
Mouth hemorrhage
1%
Pneumonitis
1%
Venous thrombosis
1%
Respiratory alkalosis
1%
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01177956) in the Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase ARM group. Side effects include: Leucopenia with 43%, Weight Decreased with 43%, Nausea with 40%, Rash with 35%, Hypomagnesaemia with 34%.

Trial Design

1 Treatment Group

Cetuximab
1 of 1
Experimental Treatment

This trial requires 21 total participants across 1 different treatment group

This trial involves a single treatment. Cetuximab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cetuximab
Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: os will be measured from the date of first dose of study drug until death from any cause. follow up for up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly os will be measured from the date of first dose of study drug until death from any cause. follow up for up to 5 years for reporting.

Closest Location

Intermountain Medical Center - Salt Lake City, UT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with histologically confirmed metastatic colorectal adenocarcinoma are eligible if their tumor has a mutant KRAS gene, as determined by a local laboratory certified by the Clinical Laboratory Improvement Amendments (CLIA) show original
The study participants must have measurable disease by using the RECIST 1.1 criteria by means of a CT scan or an MRI. show original
The person has had at least two prior treatments with 5-flourouracil, oxaliplatin, and irinotecan. show original
The patient has a very good performance status. show original
to enroll in the study People who have brain metastases that have been treated and/or are stable are allowed to enroll in the study. show original
and a life-threatening illness The study participants must have had a life expectancy of more than 3 months and a life-threatening illness. show original
Absolute neutrophil count (ANC) ≥ ≥1000/µL
A platelet count of at least 100,000/mm3 is generally considered normal. show original
Hemoglobin ≥ 9 g/dL
The subject must be a male or female aged 18 or over. show original

Patient Q&A Section

What are the signs of colorectal carcinoma (crc)?

"The most important features of CRC are anemia, anorexia, abdominal pain, constipation and weight loss. Rectal bleeding may be an important sign, and colonic bleeding should be considered a risk factor for CRC." - Anonymous Online Contributor

Unverified Answer

What causes colorectal carcinoma (crc)?

"Mutations in APC, COI1, hMSH3, p73, p53, SHH, and EGFR are involved in colorectal carcinogenesis. There have also been studies suggesting that a combination of these mutations may be responsible for the development of colorectal carcinoma.\n" - Anonymous Online Contributor

Unverified Answer

Can colorectal carcinoma (crc) be cured?

"Results from a recent clinical trial has suggested that cancer can be cured. The cure rate for patients diagnosed in localized or early stages is very high, and those patients with long-term survival. The cure rate for advanced cancers is relatively low, and those with long-term disease-free survival are uncommon." - Anonymous Online Contributor

Unverified Answer

What is colorectal carcinoma (crc)?

"About 4% of all US [colon cancer](https://www.withpower.com/clinical-trials/colon-cancer)s occur in people who had a family history of cancer. On average, a person has 1.8 family members with a history of cancer: a parent, sibling, spouse, or childhood friend." - Anonymous Online Contributor

Unverified Answer

How many people get colorectal carcinoma (crc) a year in the United States?

"Of the 3717,898 new diagnoses of CRC made in the first day of 2014, 44,914, or 1.15% of these cases, would be considered cases of invasive colorectal cancers, while the remaining cases would be adenocarcinoma of the noninvasive type. Therefore, assuming the majority of noninvasive colon cancer is due to an increase in use of colonoscopy and early detection efforts, it is possible to estimate the annual incidence of noninvasive-type colon cancer annually in the United States: 3.5 - 5." - Anonymous Online Contributor

Unverified Answer

What are common treatments for colorectal carcinoma (crc)?

"There might be some possible beneficial treatments for colorectal cancer. For example, treatment with interferon plus 5-fluoroorouracil plus leucovorin or 5-fluorouracil plus mitomycin C are possible benefits for CRC patients." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving cetuximab?

"Results from a recent clinical trial from the latest clinical trial showed that cetuximab was indeed effective for the treatment of CRC. However, the results of a previous clinical trial on its efficacy and tolerability is limited due to the use of an unconventional chemotherapy, FOLFIC. Therefore, the results of future trials of cetuximab in combination with conventional chemotherapy will play an important role." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for colorectal carcinoma (crc)?

"The survival rate for colorectal carcinoma (crc) is about 7 years. The five-year survival rate for crc is about 55 percent, and a five-year survival rate of 50 percent occurs in the elderly. At age 65, the survival rate for crc is about 70 percent. When left untreated, 50 percent of people with crc die within 10 years. However, if the cancer is checked regularly and if it is curable, survival is about 20 years in the United States from the time of its diagnosis. Also, if it isn't cured, the survival rates are about 65 percent, and the median survival time is about seven years." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing colorectal carcinoma (crc)?

"Since risk factors for CRC, that can be altered through lifestyle changes, are quite common, it is possible that CRC will be prevented through these changes. At this juncture, there is no evidence to show that CRC will be prevented by either the consumption of red or dark colored meat, or the overall amount of red meat consumed. The consumption of processed meat has no effect on the occurrence of CRC for men, but this does affect the occurrence of CRC in women. The type of meat consumed, the frequency of its intake, has no impact on the likelihood of CRC occurring, though it can reduce the risk of getting CRC on average." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cetuximab?

"No common side effects were seen in patients receiving cetuximab; they were generally associated with the concurrent use of capecitabine and the concurrent use of cetuximab+capecitabine with or without bevacizumab, and occurred in both cohorts (P=0.4). They included constipation in 20% of patients receiving capecitabine alone, and fatigue, diarrhea, nausea, vomiting, dehydration, chest pain, dyspnea, peripheral edema, and hypotension in patients receiving cetuximab-capecitabine. Fatigue was also seen in patients receiving capecitabine + bevacizumab with or without cetuximab." - Anonymous Online Contributor

Unverified Answer

How serious can colorectal carcinoma (crc) be?

"This is one of the deadliest cancers. It is classified into sub-groups based on staging, and is treated according to the TNM staging system. The ultimate endpoint of all colorectal cancer staging systems is patient survival. [Power to detect and quantify changes in survival rate between the different staging groups in CRC are available from http://www.withpower.com/clinical-trials]." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for colorectal carcinoma (crc)?

"The inclusion criteria for clinical trials are different from the criteria used for clinical practice. Patients who meet these criteria may be considered for a clinical trial by the medical team." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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