Cabozantinib for Renal Cell Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Renal Cell Adenocarcinoma+4 More
Cabozantinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help prevent cancer from returning in individuals who have had kidney cancer.

See full description

Eligible Conditions

  • Renal Cell Adenocarcinoma
  • Clear Cell Renal Cell Carcinoma (ccRCC)
  • Stage III Renal Cell Cancer AJCC v8

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Cabozantinib will improve 1 primary outcome and 5 secondary outcomes in patients with Renal Cell Adenocarcinoma. Measurement will happen over the course of Baseline and week 12 after treatment initiation.

Week 12
Objective response rate (ORR)
Week 12
Sarcopenia assessment
Week 6
Frailty assessment
Quality of life assessment: Functional Assessment of Cancer Therapy-Kidney Specific Index-19 (FKSI-19) questionnaire
Year 3
Overall survival (OS)
Year 3
Disease-free survival (DFS)

Trial Safety

Safety Estimate

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

Side Effects for

Cohort 1 - Cabozantinib, Trastuzumab for HER2+
Fatigue
76%
Aspartate aminotransferase increased
52%
Constipation
48%
Nausea
38%
Diarrhea
38%
Headache
38%
Palmar-plantar erythrodysesthesia syndrome
33%
Hypertension
33%
Mucositis oral
33%
Alanine aminotransferase increased
29%
Musculoskeletal and connective tissue disorder - Other, specify
24%
Anorexia
19%
Pain in extremity
19%
Dizziness
19%
Ataxia
19%
Cough
19%
Skin and subcutaneous tissue disorders - Other, specify
19%
Vomiting
19%
Serum amylase increased
19%
Flatulence
14%
Eye disorders - Other, specify
14%
Rash maculo-papular
14%
Hyponatremia
14%
Pain
14%
Insomnia
14%
Lipase increased
14%
Blood and lymphatic system disorders - Other, specify
14%
Dysarthria
14%
Hypothyroidism
14%
Blurred vision
14%
Abdominal pain
14%
Dysgeusia
14%
Back pain
10%
Rash acneiform
10%
Investigations - Other, specify
10%
Tracheal fistula
10%
Voice alteration
10%
Tremor
10%
Gait disturbance
10%
Hyperglycemia
10%
Generalized muscle weakness
10%
Peripheral sensory neuropathy
10%
Gastrointestinal disorders - Other, specify
10%
General disorders and administration site conditions - Other, specify
10%
Weight loss
10%
Muscle weakness lower limb
10%
Alopecia
10%
Platelet count decreased
10%
Ejection fraction decreased
10%
Pancreatitis
10%
Gastroesophageal reflux disease
10%
Stomach pain
10%
Skin infection
5%
Colitis
5%
Eye infection
5%
Duodenal hemorrhage
5%
Hypoglycemia
5%
Myalgia
5%
Depression
5%
Dyspnea
5%
Cognitive disturbance
5%
Dry skin
5%
Injury, poisoning and procedural complications - Other, specify
5%
Arthralgia
5%
Urinary incontinence
5%
Palpitations
5%
Dysmenorrhea
5%
Epistaxis
5%
Muscle weakness upper limb
5%
Hypomagnesemia
5%
Anemia
5%
Dry eye
5%
Bruising
5%
Dehydration
5%
Confusion
5%
Hot flashes
5%
Thromboembolic event
5%
Vascular disorders - Other, specify
5%
Vaginal infection
5%
Blood bilirubin increased
5%
Nervous system disorders - Other, specify
5%
Neck pain
5%
Papulopustular rash
5%
Productive cough
5%
Upper respiratory infection
5%
Hearing impaired
5%
Vertigo
5%
Ear pain
5%
Bloating
5%
Seizure
5%
Urinary urgency
5%
Toothache
5%
Dry mouth
5%
Edema trunk
5%
Dysphagia
5%
Activated partial thromboplastin time prolonged
5%
Hemorrhoids
5%
Urinary tract infection
5%
Sinus pain
5%
Facial nerve disorder
5%
Presyncope
0%
Infections and infestations - Other, specify
0%
Irregular menstruation
0%
Dyspepsia
0%
Alkaline phosphatase increased
0%
Muscle weakness right-sided
0%
Cardiac disorders - Other, specify
0%
Anxiety
0%
Personality change
0%
Tracheal mucositis
0%
Pruritus
0%
Portal vein thrombosis
0%
Nail discoloration
0%
Fall
0%
Dysphasia
0%
Paresthesia
0%
Edema limbs
0%
Restlessness
0%
Ear and labyrinth disorders - Other, specify
0%
Endocrine disorders - Other, specify
0%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02260531) in the Cohort 1 - Cabozantinib, Trastuzumab for HER2+ ARM group. Side effects include: Fatigue with 76%, Aspartate aminotransferase increased with 52%, Constipation with 48%, Nausea with 38%, Diarrhea with 38%.

Trial Design

1 Treatment Group

Treatment (cabozantinib)
1 of 1
Experimental Treatment

This trial requires 19 total participants across 1 different treatment group

This trial involves a single treatment. Cabozantinib 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.

Treatment (cabozantinib)
Drug
Patients receive cabozantinib orally once daily for 12 weeks in the absence of disease progression or unacceptable toxicity. The assigned starting dose for cabozantinib is 60 mg/day. Two dose reduction levels of cabozantinib are permitted
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
M. B.
Mehmet Bilen, Principal Investigator
Emory University

Closest Location

Emory University Hospital/Winship Cancer Institute - Atlanta, GA

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:
Subjects with Gilbert's disease will have a total bilirubin level that is ≤ 1.5 times the upper limit of normal (ULN) show original
A white blood cell count of 2500 or more per cubic millimeter is considered high. show original
The patient's platelets are above 100,000/mm³ without needing a transfusion. show original
Hemoglobin is at or above 9 grams per deciliter. show original
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) are less than 3 times the upper limit of normal show original
Serum albumin levels ≥ 2.8 g/dl are considered normal. show original
Patients with a renal mass that is consistent with a stage that is ≥ T3Nx or TanyN+ or is deemed to be unresectable by the surgeon. show original
The pre-treatment biopsy of the primary tumor showed a renal cell carcinoma with a clear cell component. show original
The Eastern Cooperative Oncology Group (ECOG) has a performance status scale of 1 or less, which means the individual is fully active, able to carry on all pre-disease activities, and has no significant limitations. show original
The patient has an absolute neutrophil count of at least 1,500 per cubic millimeter without the help of a granulocyte colony-stimulating factor. show original

Patient Q&A Section

How many people get carcinoma, renal cell a year in the United States?

"A new case of RCC will develop in 1 in 20 of those with cancer in the United States. To our knowledge, this is the first documentation of this data. Copyright © 2015 John Wiley & Sons, Ltd." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, renal cell?

"It is important that patients with [kidney cancer](https://www.withpower.com/clinical-trials/kidney-cancer) should receive an appropriately tailored discussion about any possible signs to prompt detection and to discuss options for diagnosis. summary: This article is part of a series called "What are the signs of?" that is part of the Medline Plus database (a project of the United States National Library of Medicine). The complete series covers inflammatory, infectious, endocrine and metabolic diseases, cancers, and anatomy and embryology. For more information on this series, see http://www.medlineplus.gov." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, renal cell?

"The vast majority of patients with renal cell carcinoma or other solid tumor are treated with some form of chemotherapy. Other treatments include surgery, external beam radiation, and photodynamic therapy." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, renal cell?

"Carcinoma is a form of cancer that arises in cells that line or cover organs, such as skin, lungs, stomach, esophagus, pancreas, liver, urinary tract, heart, and brain. It results in unregulated growth of cancer cells that form masses. The disease can occur in adults of any age, although most cases occur in adults ages 40-80." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, renal cell?

"The causes for the development of carcinoma, renal cell, are largely unknown. The most recent data on this disease, from the NCI database, show that in our time (from 1975 to 2000), there was a modest and steady increase in the number of patients diagnosed with carcinoma, renal cell, from 750 to 10,030 cases. This may be attributable to increased use of medical imaging. In order to properly understand the incidence and etiology of the disease, a thorough review of the entire data on the epidemiology of both renal oncology (i.e., carcinoma, renal cell) and the etiology of renal oncology is necessary." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, renal cell be cured?

"It seems that we can reduce the number of patients needing surgery by performing a preoperative nephrectomy. Nephrectomy for kidney carcinoma provides an opportunity to cure the tumor and can be performed in selected patients under close supervision." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma, renal cell?

"The incidence of [cancer, renal cell] is very low and most cases will have a primary tumour other than renal cell carcinoma. [Carcinoma, renal cell] presents an elderly male predominance and more importantly, a higher frequency of coexisting conditions like tobacco smoking or alcoholism; some of these conditions are common to renal cell carcinoma (carcinoma, renal cell)\n" - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cabozantinib?

"Most of the common side effects seen in preclinical studies were also reported with cabozantinib. The most common side effects were fatigue, nausea, dizziness, headache, diarrhea, constipation, fever, and sweating. Cabozantinib was also associated with an increased risk of liver toxicity, including hepatic adenomas, HCC, and AML, as well as other benign neoplasms. Because hepatic function must be monitored closely during treatment for carcinoma, cabozantinib should be discontinued when these adverse events occur." - Anonymous Online Contributor

Unverified Answer

Is cabozantinib typically used in combination with any other treatments?

"The data from this study suggest that cabozantinib administered as a single agent had an acceptable safety profile, but did not increase progression-free survival over placebo in this pre-selected advanced renal cell carcinoma patient population. In addition to the absence of efficacy, we found significant dose reductions of cabozantinib were associated with increased grade 3 and 5 adverse events and deaths." - Anonymous Online Contributor

Unverified Answer

How does cabozantinib work?

"Cabozantinib exerts significant effects on cell proliferation and angiogenesis in vitro. It also may have an impact on the tumor microenvironment in vitro but no evidence was found for its effects in vivo. Findings from a recent study suggest that this molecule, which acts as a tyrosine kinase inhibitor, may be a promising drug in the treatment of soft-tissue sarcomas." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, renal cell?

"There are many different types of renal cell carcinoma, which often result in different prognoses. For patients with renal cell carcinoma over 20% with stage 2 to 4 diseases, there are two clinical trials for renal cell carcinoma. For stage 2 to 4 renal cell carcinoma, clinical trials have been conducted that focus on the drug temsirolimus in treatment options." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving cabozantinib?

"Cabozantinib, which was initially developed for the treatment of kidney cancer, is in phase III clinical study for the treatment of DIPG in a large-scale, single-arm, open-label trial. Data from a recent study will be discussed in further detail in forthcoming articles." - 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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