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Spots Global Cancer Trial Database for Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary

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Trial Identification

Brief Title: Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary

Official Title: Phase II Protocol: Gemcitabine for Metastatic Cancer With Unknown Primary Site - Analysis of Symptom Benefit

Study ID: NCT00357630

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with metastatic cancer of unknown primary.

Detailed Description: OBJECTIVES: * Evaluate the efficacy of gemcitabine hydrochloride in patients with metastatic cancer of unknown primary (CUP), in terms of improved quality of life (QOL) (as measured by the FACT Physical Well Being subscale \[FACT-G\]) and reduction of symptom distress (as measured by the Memorial Symptom Assessment Scale Short Form Global Distress Index \[MSAS-SF\]). * Define clinical benefit response using a QOL instrument in patients with CUP receiving gemcitabine hydrochloride. * Correlate objective and/or evaluable tumor response with symptom and QOL response in these patients. * Explore the association between symptom response, QOL response, and clinical benefit response in these patients. * Evaluate changes in QOL in patients who have no symptom or objective response after treatment with gemcitabine hydrochloride. * Correlate EuroQOL ratings with those using symptom instruments (MSAS-SF) and quality of life instruments (FACT-G). * Evaluate changes in perceived QOL, as measured by the EuroQOL instrument, and how these changes relate to symptom response and QOL response. * Evaluate the patient's assessment of treatment burden, as measured by a single question, and how this compares to symptom response and QOL response. OUTLINE: This is an open-label, multicenter study. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43, followed by 1 week of rest (course 1). For all subsequent courses, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life (QOL) and symptom response are assessed at baseline and at weeks 8, 16, and 32 (end of treatment). Questionnaires include the Memorial Symptom Assessment Scale-Short Form, Functional Assessment of Cancer Therapy-General, Pain Visual Analog Scale, and EuroQOL. Patients' perception of symptom response and perception of treatment burden are also assessed. After completion of study treatment, patients are followed periodically for up to 3 years. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Illinois Cancer Center, Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago Westside Hospital, Chicago, Illinois, United States

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States

Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States

Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States

Elkhart General Hospital, Elkhart, Indiana, United States

Howard Community Hospital, Kokomo, Indiana, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States

Memorial Hospital of South Bend, South Bend, Indiana, United States

Saint Joseph Regional Medical Center, South Bend, Indiana, United States

McFarland Clinic, PC, Ames, Iowa, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States

Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey, United States

Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York, United States

Mercy Cancer Center at Mercy Medical Center, Canton, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States

CCOP - Columbus, Columbus, Ohio, United States

Grant Medical Center Cancer Care, Columbus, Ohio, United States

Mount Carmel Health - West Hospital, Columbus, Ohio, United States

Doctors Hospital at Ohio Health, Columbus, Ohio, United States

Grady Memorial Hospital, Delaware, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

St. Rita's Medical Center, Lima, Ohio, United States

Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States

Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States

Mercy Medical Center, Springfield, Ohio, United States

Community Hospital of Springfield and Clark County, Springfield, Ohio, United States

Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States

Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

Contact Details

Name: Victor T. Chang, MD

Affiliation: Veterans Affairs Medical Center - East Orange

Role: STUDY_CHAIR

Name: Raymond S. Lord, MD

Affiliation: West Michigan Cancer Center

Role:

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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