Itraconazole for Esophagus Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dallas VA Medical Center, Dallas, TX
Esophagus Adenocarcinoma+6 More
Itraconazole - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication used to treat fungal infections may help improve the effectiveness of radiation therapy for esophageal cancer.

See full description

Eligible Conditions

  • Esophagus Adenocarcinoma
  • Esophagus Squamous Cell Carcinoma (SCC)
  • Adenocarcinomas of the Gastroesophageal Junction

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Itraconazole will improve 1 primary outcome and 3 secondary outcomes in patients with Esophagus Adenocarcinoma. Measurement will happen over the course of 1 month..

1 month.
Levels of itraconazole and metabolites in esophageal tissue
3-4 months
Comparison of hedgehog biomarkers before and after intervention
Comparison of phosphorylated VEGFR2 and AKT before and after intervention
Percentage of pathological complete response with itraconazole

Trial Safety

Safety Estimate

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

Side Effects for

Group A: Uprifosbuvir 25 mg (Cohort 2a)
Pancreatic enzymes increased
17%
Procedural nausea
17%
Constipation
0%
Flatulence
0%
Abdominal discomfort
0%
Fatigue
0%
Vessel puncture site haematoma
0%
Nasopharyngitis
0%
Chest discomfort
0%
Contusion
0%
Amylase increased
0%
Dizziness postural
0%
Pollakiuria
0%
Menstruation delayed
0%
Nasal congestion
0%
Oropharyngeal pain
0%
Dry skin
0%
Pruritus generalised
0%
Hot flush
0%
Abdominal pain lower
0%
Faeces hard
0%
Chest pain
0%
Neck pain
0%
Pain in extremity
0%
Dizziness
0%
Insomnia
0%
Claustrophobia
0%
Abdominal pain
0%
Dyspepsia
0%
Hypoaesthesia
0%
Musculoskeletal pain
0%
Back pain
0%
Diarrhoea
0%
Vision blurred
0%
Vessel puncture site pain
0%
Rash
0%
Skin reaction
0%
Eructation
0%
Toothache
0%
Feeling cold
0%
Upper respiratory tract infection
0%
Tinnitus
0%
Vessel puncture site reaction
0%
Ocular hyperaemia
0%
Nausea
0%
Atrial fibrillation
0%
Headache
0%
Flushing
0%
Palpitations
0%
Gastritis
0%
Head discomfort
0%
Dermatitis
0%
Visual acuity reduced
0%
Paraesthesia oral
0%
Vomiting
0%
Blood creatine phosphokinase increased
0%
Arthralgia
0%
Muscle tightness
0%
Tremor
0%
Skin odour abnormal
0%
Dermatosis
0%
Sinus headache
0%
Neutropenia
0%
Abnormal faeces
0%
Pyrexia
0%
Vessel puncture site anaesthesia
0%
Vessel puncture site bruise
0%
Vulvitis
0%
Lipase increased
0%
Cough
0%
Epistaxis
0%
Rhinorrhoea
0%
Pruritus
0%
Somnolence
0%
Erythema
0%
Sensory loss
0%
Leukopenia
0%
Dysuria
0%
Dysgeusia
0%
Breast enlargement
0%
Musculoskeletal stiffness
0%
Myalgia
0%
Dry mouth
0%
Rash papular
0%
This histogram enumerates side effects from a completed 2015 Phase 1 & 2 trial (NCT01974687) in the Group A: Uprifosbuvir 25 mg (Cohort 2a) ARM group. Side effects include: Pancreatic enzymes increased with 17%, Procedural nausea with 17%, Constipation with 0%, Flatulence with 0%, Abdominal discomfort with 0%.

Trial Design

1 Treatment Group

Itraconazole
1 of 1
Experimental Treatment

This trial requires 78 total participants across 1 different treatment group

This trial involves a single treatment. Itraconazole 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.

Itraconazole
Drug
Itraconazole capsule 300mg twice daily for 6-8 weeks following chemoradation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-4 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3-4 months for reporting.

Who is running the study

Principal Investigator
D. W.
David Wang, Staff Physician
Dallas VA Medical Center

Closest Location

Dallas VA Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients diagnosed with localized (locoregional) esophageal cancer
(LGEC) have the option of surgical resection or radiation therapy show original

Patient Q&A Section

Can adenocarcinoma be cured?

"Ad and SCC have similar survivals; local, regional, and distant metastases also display similar survivals. In a recent study, findings, we observed poor survival for lymph nodes and the liver. Overall survival is lower than expected considering the high survival of the survivors who made it through the neoadjuvant treatment. In a recent study, findings indicate that most patients will not be cured. We must explore the use of new therapeutics. Future treatment should aim at eradication of the diseased lymph nodes and the liver, and not at curing the cancer cells." - Anonymous Online Contributor

Unverified Answer

What are the signs of adenocarcinoma?

"Most cases of adenocarcinoma can be accurately diagnosed by a panel of common clinical signs. However, only a few can be reliably diagnosed in all cases, but only if there is a high index of suspicion in the history and physical examination. The use of computed tomography has greatly improved the detection of adenocarcinoma but can provide clues about metastatic spread of the neoplasm." - Anonymous Online Contributor

Unverified Answer

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

"Adenocarcinoma is prevalent, and some clinicians do not routinely collect pathologic material during procedures to obtain adequate tissue for diagnosis. The number of patients with adenocarcinoma should increase substantially within the next few years owing to the increase in diagnosis of polypoid adenocarcinoma of the colon." - Anonymous Online Contributor

Unverified Answer

What causes adenocarcinoma?

"Adenocarcinoma is found to be more commonly in females and to occur more commonly in the left lung. It may have a multifactorial cause, and this must be considered when treatment is aimed at patients with this problem. At an early stage, radiotherapy can be of great benefit, avoiding many deaths if the disease is localized." - Anonymous Online Contributor

Unverified Answer

What are common treatments for adenocarcinoma?

"Adenocarcioma is often treated through a variety of therapeutic modalities. Chemotherapy is often used along with surgery to attempt better tumor control, but can exacerbate symptoms in some patients and so the overall treatment of adenocarcinoma must be individualized. Tumor markers are often used to monitor disease progression or regression of existing tumors, and may indicate additional risks for developing metastatic disease. Radiosurgery is being reconsidered and has become the preferred treatment of choice, especially in the brain. Radiation and surgery can be used if tumors in the bone and lymph nodes become metastatic. Radiotherapy has been increasingly employed to treat sarcomas, and may prove helpful in controlling distant metastasis." - Anonymous Online Contributor

Unverified Answer

What is adenocarcinoma?

"About 2 to 10 in 10 adults in the United States are diagnosed with adenocarcinoma of the lung every year. Adenocarcinoma is the most common form of bronchogenic carcinoma and the fourth most common cause of cancer death. It is also a very variable cancer in pathogenesis and symptoms. Adenocarcinoma is an epithelial tumour, that accounts for approximately 40% of all respiratory neoplasms." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing adenocarcinoma?

"Women who used oral contraceptives, were older than 55 years at time of diagnosis, had more family history of cancer and had more synchronous adenocarcinoma in the synchronous primary cancer were also at an increased risk of developing an adenocarcinoma in a subsequent pregnancy. These women had a significantly higher risk of adenocarcinoma during a subsequent pregnancy." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving itraconazole?

"We have conducted an unpublished trial evaluating the efficacy and safety of itraconazole in cancer patients. We have also used itraconazole in postoperative perioperative prophylaxis of invasive fungal infections." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in itraconazole for therapeutic use?

"Itraconazole achieves significant and sustained reduction of voriconazole trough levels in patients with invasive aspergillosis, which was associated with a higher rate of success for treatment with itraconazole. Further studies are warranted to understand if voriconazole/itraconazole drug combination is superior to itraconazole alone in invasive aspergillosis treatment." - Anonymous Online Contributor

Unverified Answer

What is itraconazole?

"The incidence rate of hepatic failure after six months of treatment with itraconazole is lower when patients with a pre-existing hepatic impairment are treated with itraconazole. The overall incidence and severity of hepatic impairment is not influenced by the initial severity of alcoholic liver disease. As of October 2005, itraconazole is not recommended in patients with a cirrhosis or chronic hepatitis/cirrhosis due to the increased risk of liver toxicity." - Anonymous Online Contributor

Unverified Answer

Does itraconazole improve quality of life for those with adenocarcinoma?

"Treatment with itraconazole resulted in improvements in patient-reported outcomes for patients with advanced [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer). These improvements may be due to a direct antitumor effect of itraconazole on cancer cells." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of itraconazole?

"Itraconazole might cause a variety of side effects including nausea and vomiting, stomach swelling, dizziness, hair loss, weakness, itchiness, and rash. These effects are all transient and resolve in a short time frame. They may occur more frequently with the increase of the daily dose, irrespective of the duration of treatment, and in some cases can persist when treatment is stopped. Itraconazole was shown to cause serious or severe reactions in less than 1% of patients and should be carefully monitored." - 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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