Regorafenib for Adenocarcinoma

1
Effectiveness
2
Safety
Memorial Sloan Kettering Cancer Center at Commack, Commack, NY
Adenocarcinoma+1 More
Regorafenib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Adenocarcinoma

Study Summary

This study is evaluating whether taking regorafenib instead of standard chemotherapy will have better, worse or the same results.

See full description

Eligible Conditions

  • Adenocarcinoma
  • Metastatic Colorectal Adenocarcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Regorafenib will improve 1 primary outcome and 4 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of 16 weeks.

16 weeks
disease control rate
progression free survival
2 years
duration of stable disease
overall survival
toxicity

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Side Effects for

Napabucasin Plus FOLFOX6
Diarrhoea
82%
Nausea
76%
Fatigue
71%
Vomiting
57%
Abdominal pain
53%
Neuropathy peripheral
30%
Dyspnoea
27%
Anaemia
25%
Neutrophil count decreased
23%
Constipation
23%
Weight decreased
22%
Hypokalaemia
21%
Oedema peripheral
20%
Dehydration
18%
Cough
17%
Pyrexia
17%
Peripheral sensory neuropathy
17%
Neutropenia
17%
Thrombocytopenia
16%
Back pain
15%
Platelet count decreased
15%
Chromaturia
13%
Dysgeusia
13%
Mucosal inflammation
13%
Temperature intolerance
13%
White blood cell count decreased
12%
Urinary tract infection
12%
Dizziness
11%
Depression
11%
Anxiety
10%
Dysphagia
10%
Stomatitis
10%
Ascites
10%
Hyponatraemia
10%
Abdominal distension
9%
Headache
9%
Insomnia
9%
Pain in extremity
8%
Asthenia
8%
Arthralgia
8%
Alopecia
8%
Blood alkaline phosphatase increased
7%
Urine ketone body present
7%
Pulmonary embolism
7%
Leukopenia
6%
Dyspepsia
6%
Blood bilirubin increased
6%
Lymphopenia
6%
Palmar-plantar erythrodysaesthesia syndrome
5%
Hypertension
5%
Abdominal pain upper
5%
Urine leukocyte esterase positive
5%
Rash
5%
Proteinuria
5%
Sepsis
5%
Gastrooesophageal reflux disease
5%
Flatulence
4%
Chills
4%
Dry mouth
3%
Muscle spasms
3%
Myalgia
3%
Epistaxis
3%
Pleural effusion
2%
Pneumonia
2%
pelvic fracture
2%
Disease progression
2%
Haematemesis
2%
malignant neoplasm progression
2%
Mental status changes
2%
Confusional state
2%
syncope
1%
Enterocutaneous fistula
1%
Lung abscess
1%
Hypoxia
1%
Perirectal abscess
1%
fall
1%
deep vein thrombosis
1%
Septic shock
1%
Upper gastrointestinal haemorrhage
1%
Gastrointestinal haemorrhage
1%
embolism
1%
pelvic venous thrombosis
1%
pancreatic carcinoma
1%
Clostridium difficile colitis
1%
Pneumonia aspiration
1%
somnolence
1%
Chest pain
1%
Cholangitis
1%
Salmonella sepsis
1%
haematoma
1%
Acute kidney injury
1%
Febrile neutropenia
1%
Acute respiratory failure
1%
Influenza
1%
hip fracture
1%
Atrial fibrillation
1%
Large intestine perforation
1%
Colitis
1%
Death
1%
Oesophagitis
1%
Haemorrhage intranial
1%
Ischaemic cerebral infarction
1%
Hyperglycaemia
1%
subdural haematoma
1%
Enteritis
0%
migraine
0%
Pneumonitis
0%
Rectal haemorrhage
0%
overdose
0%
metastases to central nervous system
0%
Angina pectoris
0%
Urosepsis
0%
Small intestinal obstruction
0%
Hepatic function abnormal
0%
Vision blurred
0%
Haemoptysis
0%
hemiparesis
0%
Cardiac failure congestive
0%
Failure to thrive
0%
Intestinal obstruction
0%
Viral sepsis
0%
Musculoskeletal pain
0%
hypertension
0%
Cholecystitis
0%
Hypoglycaemia
0%
Respiratory failure
0%
Cardiac arrest
0%
Bile duct obstruction
0%
Hepatic failure
0%
cerebrovascular accident
0%
Liver function test abnormal
0%
Peritonitis bacterial
0%
colon cancer metastatic
0%
Myocardial infarction
0%
encephalopathy
0%
Pain
0%
malignant pleural effusion
0%
headache
0%
Decreased appetite
0%
Obstruction gastric
0%
Multi-organ failure
0%
Peripheral swelling
0%
Muscular weakness
0%
Nephrolithiasis
0%
Streptococcal bacteraemia
0%
Bacteraemia
0%
Pyuria
0%
gastroenteritis radiation
0%
hypovolaemic shock
0%
hypotension
0%
Cholecystitis acute
0%
Hyperbilirubinaemia
0%
Megacolon
0%
Pancreatitis
0%
Chest discomfort
0%
Aspiration
0%
stoma site haemorrhage
0%
Large instestinal obstruction
0%
Bone pain
0%
spinal cord compression
0%
aphasia
0%
Hypomagnesaemia
0%
Blood creatinine increased
0%
Pathological fracture
0%
Device related infection
0%
Non-cardiac chest pain
0%
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT02024607) in the Napabucasin Plus FOLFOX6 ARM group. Side effects include: Diarrhoea with 82%, Nausea with 76%, Fatigue with 71%, Vomiting with 57%, Abdominal pain with 53%.

Trial Design

2 Treatment Groups

Control
Regorafenib

This trial requires 11 total participants across 2 different treatment groups

This trial involves 2 different treatments. Regorafenib 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.

Regorafenib
Drug
This is an open-label, phase II study of regorafenib for patients with metastatic colorectal carcinoma. The treatment will be repeated every week for three weeks on and one week off. Patients will be evaluated for response after every 2 cycles (8 weeks).
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center at Commack - Commack, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Adenocarcinoma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People with metastatic colorectal cancer that hasn't been treated, or those who haven't responded to any first line chemotherapy treatment that uses 5-FU (such as FOLFOX or FOLFIRI), have a five year survival rate of about 12%. show original
This patient has metastatic cancer that has spread to one or more sites, including the liver, lung, lymph nodes, and peritoneum show original
Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) levels should be ≤ 2.5 xULN (≤ 5 x ULN for subjects with liver involvement of their cancer). show original
Lipase ≤ 1.5 x the ULN
This patient has a 0 or 1 ECOG show original
The alkaline phosphastase limit for a person is ≤ 2.5 x the upper limit of the normal range (≤ 5 x the upper limit of the normal range for subjects with liver involvement of their cancer). show original
The life expectancy of at least 12 weeks means that a baby is expected to live for at least 12 weeks. show original
Age ≥ 18 years.
Histologically proven colorectal adenocarcinoma
Bilirubin levels lower than 1.5 times the upper limit of normal are considered normal. 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 signs of adenocarcinoma?

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The key signs are: a mass lesion on chest X-ray; enlarged lymph nodes in the neck; and bone or bone marrow metastasis. In patients less than 50 years old, the key diagnosis and signs of advanced cancer can be visualized on mammography and/or magnetic resonance imaging (MRI). Most patients over 50 years old present with bone metastasis or pleural invasion. Other signs and symptoms of metastatic disease include weight loss and/or loss of appetite.

Unverified Answer

What are common treatments for adenocarcinoma?

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Rare cases of adenocarcinoma in the lung can be treated with surgery, targeted therapy, or immunotherapy. If metastasis to the brain occurs, systemic therapy with targeted therapy, local treatment of brain and bone metastases, or local treatment of extracranial metastases can improve survival in most cases. The prognosis of lung cancer is dependent on the patient age and the size and stage of the tumor.

Unverified Answer

How many people get adenocarcinoma a year in the United States?

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Approximately 230,000 people in the United States have adenocarcinoma a year, more than half of whom are diagnosed in the first four stages of the disease.

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What is adenocarcinoma?

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Adenocarcinoma is the most prevalent form of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) and is the most common form of cancer encountered by primary healthcare doctors. It is often detected by a persistent cough and a nonproductive cough after the age of 46.

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Can adenocarcinoma be cured?

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The stage-adjusted survival for patients treated with adjuvant systemic therapy (in addition to surgery) was approximately 25% higher than that for those treated with surgery alone. Patients who undergo surgery only as salvage therapy for locally advanced or metastatic disease have the lowest long-term survival.

Unverified Answer

What causes adenocarcinoma?

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Adenocarcinomas in colon cancers are rare. The adenocarcinoma subtype has become increasingly recognized as a distinct entity for multiple reasons. As part of the advancement of knowledge of this disease, we report a single center case of a rare and uncommon (0.24% of all colorectal cancers), as well as the first ever reported adenocarcinoma of the appendix with a distinct clinical presentation and survival for this disease.

Unverified Answer

What is the primary cause of adenocarcinoma?

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Adenocarcinoma is not caused by a single etiologic factor. Instead, it is probably caused by different environmental conditions operating synergistically. The incidence of adenocarcinoma will increase as the population ages.

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How does regorafenib work?

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Both PD-8603 and PD-9402 improved progression-free survival and overall survival in patients with metastatic colorectal cancer (CRC) when used as monotherapeutic agents in a dose-dense, sequential fashion. The addition of sorafenib to regorafenib did not significantly change the duration of response.

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What are the common side effects of regorafenib?

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In patients undergoing regorafenib for advanced colorectal cancer, common adverse reactions included diarrhoea and nausea. More serious adverse effects in more than 10% of patients included liver failure, fatigue, anaemia, hypertension, and skin reaction.

Unverified Answer

Who should consider clinical trials for adenocarcinoma?

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Data from a recent study suggested that the clinical trial population for adenocarcinoma is significantly larger than what had previously been suggested. Data from a recent study also indicated that patient characteristics are important for selecting a study population that will maximize the potential for finding statistically and clinically significant differences among the various treatment arms.

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What is the latest research for adenocarcinoma?

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There are many new treatments for this rare cancer such as biologic therapy where you can choose which one works best for your cancer. We also found that surgery and radiation therapy are still used by patients who need treatment, even though there are more new treatments that physicians can prescribe and order to improve quality of life for patients with this aggressive type of cancer. In a study that used biologic therapy on a large scale for patients with adenocarcinoma, only 10% of patients were alive 5.4 years after treatment, but by contrast the average survival for patients undergoing conventional treatment in a similar study was over 4 years. Please visit [www.withpower.

Unverified Answer

What is the average age someone gets adenocarcinoma?

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Adenocarcinoma affects the lungs of young and middle aged adults. The average age for onset varies between 30 and 40 years. The average age for death is 58 years old. These tumors are characterized, in general, by a well differentiated morphology and a favorable survival.

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