Atezolizumab for Cancer of Colon

Phase-Based Estimates
2
Effectiveness
3
Safety
Saint Luke's Cancer Institute - Fruitland, Fruitland, ID
Cancer of Colon+8 More
Atezolizumab - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Cancer of Colon

Study Summary

This study is evaluating whether a combination of chemotherapy and immunotherapy may be more effective than chemotherapy alone in treating colon cancer.

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Eligible Conditions

  • Cancer of Colon
  • Colonic Neoplasms
  • Lynch Syndrome
  • Colon Adenocarcinoma
  • Stage III Colon Cancer AJCC v7
  • Colorectal Neoplasms, Hereditary Nonpolyposis
  • Stage IIIA Colon Cancer AJCC v7
  • DNA Repair Disorder
  • Stage IIIB Colon Cancer AJCC v7
  • Stage IIIC Colon Cancer AJCC v7

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Atezolizumab will improve 1 primary outcome and 2 secondary outcomes in patients with Cancer of Colon. Measurement will happen over the course of Up to 30 days after last treatment.

Year 5
Overall survival
Year 5
Disease free survival (DFS)
Day 30
Incidence of adverse events

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Arm II (combination chemotherapy)
Arm I (combination chemotherapy, atezolizumab)

This trial requires 700 total participants across 2 different treatment groups

This trial involves 2 different treatments. Atezolizumab 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 3 and have had some early promising results.

Arm I (combination chemotherapy, atezolizumab)Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes starting on day 1 of cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity.
Arm II (combination chemotherapy)Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Leucovorin
FDA approved
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the time from randomization to death, from any cause, assessed up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the time from randomization to death, from any cause, assessed up to 5 years for reporting.

Closest Location

Saint Luke's Cancer Institute - Fruitland - Fruitland, ID

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Based on a clinical assessment of the patient's imaging, the study team determined that there was no evidence of residual lymph node disease or metastatic disease show original
This is a cancer that starts in the colon and has spread to the lymph nodes or to other parts of the body. show original
; The presence of deficient DNA mismatch repair (dMMR) can be determined by immunohistochemistry (IHC) for MMR protein expression show original
Patients whose tumors show MSI-H (a certain pattern of DNA damage) by polymerase chain reaction (PCR)-based assay are not eligible to participate in this study, unless they also have MMR testing by immunohistochemistry (IHC) and are found to have dMMR (loss of one or more MMR proteins). show original
A tumor must be completely resected, and if it is adherent to adjacent structures, it must be resected en bloc show original
A patient with a stage III colon adenocarcinoma is eligible for the study if the tumor is confined to the colon and not the rectum, and the other cancers of lower stage are removed in the en bloc resection. show original
The location of the tumor will be categorized based on where it is in relation to the splenic flexure show original
Patients >= 16 years of age: Lansky >= 60% The percentage of patients with Lansky scores of >= 50% decreases with age show original
Patients who are known to have Lynch syndrome, have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2), and have been shown to be dMMR by IHC are eligible to participate
chemotherapy No prior medical therapy (including chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy has been given for the current colon cancer, except for one cycle of mFOLFOX6 chemotherapy. show original

Patient Q&A Section

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

What are the common side effects of atezolizumab?

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Atezolizumab was well tolerated, but the side effects of the drug were consistent with the known properties of monoclonal antibodies and included fatigue, weight loss, and infections.

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Is atezolizumab safe for people?

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The safety of atezolizumab was evaluated in 929 people with stage III or IV CRC. Tumor shrinkage was seen in 97% of patients (100% with TGF beta R-expressing tumors). Serious adverse events were rare (4%) in the overall group, but were more common (7%) in the atezolizumab group.

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What are common treatments for cancer of colon?

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Most patients are receiving and in the treatment of cancer of colon. Patients are receiving chemotherapy and/or radiotherapy the majority of the time. In fact, most patients still receive no therapy before surgery. The data from this study are the same as [Power(http://www.withpower.com/clinical-trials/cancer-of-colon) and [SIGECARE-BIOTAGE] [Kanaka and Hegazy, Clin. Oncol.]]. The goal of this study is find out which treatments are not being provided for those patients who are not receiving treatment. Clin. Oncol. (2016).

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What causes cancer of colon?

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Hereditary factors are a key factor in familial colon cancer. Identifying and following these families may decrease the risk of colon cancer. Furthermore, colorectal neoplasm can be a potential clue for the development of new biomarkers.

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What is cancer of colon?

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Current data indicate that the prevalence of colon cancer is increasing at a rate two to three times higher than that of the general US population.

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How many people get cancer of colon a year in the United States?

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Colorectal cancer is the leading nonprostate cancer among women, among men, and in all races combined. Among men, colorectal cancer accounts for more deaths from cancer than any other cancer.

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What are the signs of cancer of colon?

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Signs of cancer of colons are not all obvious. Patients may have signs unrelated to the presence of CRC, such as weight loss, change in bowel habits or tiredness. The diagnosis of cancer of colons needs a high index of suspicion from doctors who are aware of appropriate examinations, examinations and test results.

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Can cancer of colon be cured?

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Current medical therapies, including drugs and surgery, are effective for the prevention and treatment of colon cancer. The main drawback is that it may return even with proper treatment. However, it can be eliminated by removing the cause, namely, lifestyle modifications such as nutritional deficiencies, smoking, low-grade inflammation, and a high-fat diet, including red meats.

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What is the average age someone gets cancer of colon?

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Results from a recent paper of our study suggest that patients should be informed about the average age at which colon cancer is expected to occur, and how much time elapsed between the onset of symptoms and medical attention.

Unverified Answer

Is atezolizumab typically used in combination with any other treatments?

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The majority of atezolizumab treated, metastatic UC patients with ECOG >2 received a first line atezolizumab treatment that included chemotherapy (83.3%) or chemotherapy and surgery (12.0%). Overall, 18% of patients receiving atezolizumab treatment received a second-line treatment.

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How serious can cancer of colon be?

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The major risk of [colon cancer](https://www.withpower.com/clinical-trials/colon-cancer) is colon cancer and not a subtype of cancer, i.e. rectal cancer. The major risk to rectum cancers is recurrence and not stage or subtype. Colon cancer is not a lethal disease.

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How quickly does cancer of colon spread?

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Of the 3,100 patients enrolled, there were 740 patients (23.5%) in whom colon cancer spread to the liver, and 865 patients (27.5%) showed signs of disease on imaging examination. The majority of these cases had spread by the middle of the second year after the first diagnosis of colorectal cancer. These data suggest that routine imaging tests of the liver should be included in the treatment for patients with colorectal cancer.

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