Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary
- Conditions
- Carcinoma of Unknown PrimaryPain
- Registration Number
- NCT00357630
- Lead Sponsor
- Eastern Cooperative Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy, in terms of improved quality of life and reduction of symptom distress
- Secondary Outcome Measures
Name Time Method Survival Changes in symptom distress, pain, and quality of life at 8, 16, and 32 weeks Tumor response and duration
Trial Locations
- Locations (37)
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
🇺🇸Voorhees, New Jersey, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
🇺🇸Chicago, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸Marlton, New Jersey, United States
Mercy Cancer Center at Mercy Medical Center
🇺🇸Canton, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States