Phase II Protocol: Gemcitabine for Metastatic Cancer With Unknown Primary Site - Analysis of Symptom Benefit
- 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
- Define clinical benefit response using a QOL instrument in patients with CUP receiving
- Correlate objective and/or evaluable tumor response with symptom and QOL response in
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Efficacy, in terms of improved quality of life and reduction of symptom distress
Victor T. Chang, MD
Veterans Affairs Medical Center - East Orange
United States: Federal Government
|Hinsdale Hematology Oncology Associates||Hinsdale, Illinois 60521|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|Mercy Cancer Center at Mercy Medical Center||Canton, Ohio 44708|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|St. Rita's Medical Center||Lima, Ohio 45801|
|Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center||La Crosse, Wisconsin 54601|
|Memorial Hospital of South Bend||South Bend, Indiana 46601|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Saint Joseph Regional Medical Center||South Bend, Indiana 46617|
|Our Lady of Mercy Medical Center Comprehensive Cancer Center||Bronx, New York 10466|
|Adena Regional Medical Center||Chillicothe, Ohio 54601|
|Doctors Hospital at Ohio Health||Columbus, Ohio 43228|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|Grady Memorial Hospital||Delaware, Ohio 43015|
|Fairfield Medical Center||Lancaster, Ohio 43130|
|Strecker Cancer Center at Marietta Memorial Hospital||Marietta, Ohio 45750|
|Licking Memorial Cancer Care Program at Licking Memorial Hospital||Newark, Ohio 43055|
|Community Hospital of Springfield and Clark County||Springfield, Ohio 45505|
|Genesis - Good Samaritan Hospital||Zanesville, Ohio 43701|
|University of Illinois Cancer Center||Chicago, Illinois 60612-7243|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Elkhart General Hospital||Elkhart, Indiana 46515|
|Howard Community Hospital||Kokomo, Indiana 46904|
|Lakeland Regional Cancer Care Center - St. Joseph||St. Joseph, Michigan 49085|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton||Marlton, New Jersey 08053|
|Fox Chase Virtua Health Cancer Program at Virtua West Jersey||Voorhees, New Jersey 08043|
|Mount Carmel Health - West Hospital||Columbus, Ohio 43222|
|Veterans Affairs Medical Center - Chicago Westside Hospital||Chicago, Illinois 60612|
|Center for Cancer Therapy at LaPorte Hospital and Health Services||La Porte, Indiana 46350|
|Mercy Medical Center||Springfield, Ohio 45504|
|McFarland Clinic, PC||Ames, Iowa 50010|
|Grant Medical Center Cancer Care||Columbus, Ohio 43215|
|Mount Carmel St. Ann's Cancer Center||Westerville, Ohio 43081|
|Regional Cancer Center at Memorial Medical Center||Springfield, Illinois 62781-0001|