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Tyrosine Kinase Inhibitor

Afatinib and Paclitaxel for Esophageal Cancer

Phase 2

Waitlist Available

Led By Yelena Janjigian, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat cancer that has progressed despite prior treatment with trastuzumab.

Eligible Conditions

Esophageal Cancer
Stomach Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy

Secondary outcome measures

Number of Participants Evaluated for Toxicity

Side effects data

From 2023 Phase 2 trial • 42 Patients • NCT01522768

90%

Diarrhea

50%

Fatigue

43%

Rash acneiform

31%

Anemia

29%

Hyperglycemia

29%

Anorexia

19%

Papulopustular rash

17%

Vomiting

17%

Mucositis oral

14%

Dry skin

14%

Abdominal Pain

14%

Dehydration

14%

Dyspnea

14%

Hypomagnesemia

14%

Hypokalemia

12%

Lymphocyte count decreased

12%

Aspartate aminotransferase increased

12%

Alkaline phosphatase increased

12%

Hypoalbuminemia

12%

White blood cell decreased

10%

Nausea

Acute kidney injury

Headache

Erythema multiforme

Dysphagia

INR increased

Blood bilirubin increased

Alanine aminotransferase increased

Back pain

Arthralgia

Gastric hemorrhage

Hypocalcemia

Paronychia

Creatinine increased

Edema limbs

Hypophosphatemia

Pruritus

Gastrointestinal disorders - Other

Constipation

Weight loss

Acidosis

Generalized muscle weakness

Infections and infestations - Other

Pain

Hypoxia

Hyponatremia

Ataxia

Confusion

Alopecia

Blurred vision

Death NOS

Dizziness

Hypoglycemia

Myalgia

Platelet count decreased

Activated partial thromboplastin time prolonged

Rash maculo-papular

Urinary frequency

Hoarseness

Hypotension

Pleural effusion

Productive cough

Cholecystitis

Thromboembolic event

Apnea

Chest pain - cardiac

Movements involuntary

Abdominal distension

Conjunctivitis

Non-cardiac chest pain

Renal and urinary disorders - Other

Urticaria

Dry Mouth

Urine discoloration

Hiccups

Epistaxis

Palpitations

Aspiration

Esophageal varices hemorrhage

Gait disturbance

Sepsis

Gen disorders & admin site conditions Other, spec

Hematoma

Seizure

Sinus tachycardia

Surgical and medical procedures - Other

Muscle weakness left-sided

Muscle weakness lower limb

Muscle weakness upper limb

Paresthesia

Ventricular arrhythmia

100%

80%

60%

40%

20%

Study treatment Arm

Afatinib and Paclitaxel

Trial Design

1Treatment groups

Experimental Treatment

Group I: Afatinib and PaclitaxelExperimental Treatment1 Intervention

This is a multi-institution, open-label, non-randomized, Phase II evaluation of oral afatinib daily and intravenous paclitaxel (weekly, 3 weeks on, 1 week off) in patients with trastuzumab refractory HER2-positive metastatic or recurrent esophagogastric adenocarcinoma. An initial biopsy prior to the start of therapy is required for the correlative studies evaluating the biologic effects of afatinib. It will be obtained for all patients whose tumors are feasible to biopsy. At the site investigator's discretion, a second biopsy will also be obtained. At the discretion of the MSK Principal Investigator, select participants who show response on this study and then progress may be asked to have an optional third biopsy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Afatinib and Paclitaxel

2012

Completed Phase 2

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,856 Total Patients Enrolled

Boehringer IngelheimIndustry Sponsor

2,507 Previous Clinical Trials

11,340,865 Total Patients Enrolled

University of Southern CaliforniaOTHER

906 Previous Clinical Trials

1,596,246 Total Patients Enrolled

Frequently Asked Questions

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

How many different places can people participate in this clinical trial?

"Currently, 9 medical sites are running this trial. They are situated in Rockville Centre, Middletown and Montvale as well as 6 other locations. If you want to participate in the study, try to choose a clinic near you to reduce travel time commitments."

Answered by AI

What are Afatinib and Paclitaxel most effective against?

"Afatinib and Paclitaxel can be used to treat a variety of conditions, such as neoplasm metastasis, kaposi sarcoma, and advance directives."

Answered by AI

Is Afatinib and Paclitaxel more likely to cause harm than other cancer treatments?

"While there is some evidence to support the safety of these drugs, as this is only a phase 2 trial, neither Afatinib nor Paclitaxel have been proven effective."

Answered by AI

Are Afatinib and Paclitaxel new drugs being tested?

"The Afatinib and Paclitaxel combination was first studied in 1997. Out of the 1232 clinical trials completed thus far, 905 are still recruiting patients. Many of these active trials are based in Rockville Centre, New jersey."

Answered by AI

How many patients have enrolled in this research project?

"Unfortunately, this clinical trial is no longer enrolling patients. Although, if you are interested in other studies, 548 trials for malignant neoplasm of stomach and 905 for Afatinib and Paclitaxel are ongoing and actively recruiting participants."

Answered by AI

Are there any slots left for volunteers in this clinical trial?

"Unfortunately, this particular clinical trial is not currently admitting patients. The first posting was on March 1st, 2012 and the most recent edit was on March 18th, 2022. However, there are 548 other trials for malignant neoplasm of stomach and 905 for Afatinib and Paclitaxel that are still enrolling."

Answered by AI

Recent research and studies

egfrJournal

egfr and met Amplifications Determine Response to HER2 Inhibition in erbb2-amplified Esophagogastric Cancer

Sanchez-Vega, Francisco, Jaclyn F. Hechtman, Pau Castel, Geoffrey Y. Ku, Yaelle Tuvy, Helen Won, Christopher J. Fong, et al.. 2019. “egfr and met Amplifications Determine Response to HER2 Inhibition in erbb2-amplified Esophagogastric Cancer”. Cancer Discovery. American Association for Cancer Research (AACR). doi:10.1158/2159-8290.cd-18-0598.

clinicaltrials.govStudy

Afatinib and Paclitaxel in Patients With Advanced HER2-Positive Trastuzumab-Refractory Advanced Esophagogastric Cancer

2012. "Afatinib and Paclitaxel in Patients With Advanced HER2-Positive Trastuzumab-Refractory Advanced Esophagogastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01522768.