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Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction

Last Updated: 2018-07-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-01-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether capecitabine is more effective when given alone or together with sunitinib malate in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.

PURPOSE: This randomized phase II trial is studying how well capecitabine works compared with capecitabine given together with sunitinib malate as first-line therapy in treating patients with metastatic cancer of the esophagus or gastroesophageal junction.

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Detailed Description

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OBJECTIVES:

Primary

* Compare the progression-free survival of elderly (age ≥ 65 years) and/or poor performance status patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with capecitabine with verus without sunitinib malate.
* Report other indicators of efficacy with these regimens, including the confirmed response rate, overall survival, time to tumor progression, duration of response, and time to treatment failure.
* Compare the adverse event profiles of these regimens in these patients.

Secondary

* Explore whether certain key proteins associated with anti-VEGF therapy are able to predict tumor response.
* Bank paraffin-embedded tissue blocks or slides, and blood products for future studies.

OUTLINE: This is a multicenter study. Patients are stratified according to gender (male vs female), ECOG performance status (0 vs 1 vs 2), and age (≥ 65 years vs \< 65 years). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion.
* Arm II: Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected at baseline for evaluation of protein markers as possible predictors of tumor response to this regimen. Samples are analyzed by IHC for expression levels of markers

After completion of study therapy, patients are followed periodically for 3 years.

Conditions

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Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion.

Group Type EXPERIMENTAL

capecitabine

Intervention Type DRUG

Given orally

Arm II

Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.

Group Type EXPERIMENTAL

capecitabine

Intervention Type DRUG

Given orally

sunitinib malate

Intervention Type DRUG

Given orally

Interventions

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capecitabine

Given orally

Intervention Type DRUG

sunitinib malate

Given orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No known CNS metastases

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-2 and age ≥ 65 years OR PS 2 and age ≥ 18 years but \< 65 years
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin normal
* Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance ≥ 60mL/min
* AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to provide tissue samples for central review and research purposes
* Able to swallow pills
* No immunocompromised patients (other than related to the use of corticosteroids), including patients known to be HIV-positive
* No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* No uncontrolled intercurrent illness including, but not limited to, any of the following:

* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situations that would limit compliance with study requirements
* No NYHA class III or IV heart failure
* No uncontrolled hypertension except at the discretion of treating oncologist
* No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix
* No known dihydropyrimidine dehydrogenase deficiency (DPD)

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy, radiotherapy, immunotherapy, or biological therapy for recurrent or metastatic cancer

* Prior chemotherapy or radiotherapy are allowed if they had been administered as adjuvant or neoadjuvant therapy and a complete surgical resection of the original cancer had been achieved
* No prior sunitinib malate
* No prior radiotherapy to \> 30% of the marrow cavity at any time
* More then 4 weeks since prior major surgery
* At least 12 days since prior and no concurrent CYP3A4 inducers, including rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's wort, efavirenz, and tipranavir
* At least 7 days since prior and no concurrent CYP3A4 inhibitors, including azole antifungals (ketoconazole, itraconazole), clarithromycin, erythromycin, diltiazem, verapamil, HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir), and delavirdine
* No other concurrent specific treatment (other than hormonal therapy) in patients with a history of prior malignancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aminah Jatoi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Illinois CancerCare - Bloomington

Bloomington, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Illinois CancerCare - Canton

Canton, Illinois, United States

Site Status

Illinois CancerCare - Carthage

Carthage, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Illinois CancerCare - Eureka

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Illinois CancerCare - Galesburg

Galesburg, Illinois, United States

Site Status

Illinois CancerCare - Havana

Havana, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Illinois CancerCare - Macomb

Macomb, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

Illinois CancerCare - Monmouth

Monmouth, Illinois, United States

Site Status

OSF Holy Family Medical Center

Monmouth, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Illinois CancerCare - Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Illinois CancerCare - Pekin

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois CancerCare - Peru

Peru, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Illinois CancerCare - Princeton

Princeton, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status