Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary
NCT ID: NCT00357630
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2006-06-30
Brief Summary
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PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with metastatic cancer of unknown primary.
Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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gemcitabine hydrochloride
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed poorly differentiated carcinoma or adenocarcinoma of unknown primary
* Diagnosis based on biopsy and conventional imaging, including CT scans of the chest, abdomen, and pelvis with or without positron emission tomography (PET) scans or other specialized tests, performed within the past 4 weeks
* Must not have any of the following clinical features:
* Squamous cell carcinoma in the lymph nodes of the neck or inguinal nodes only
* Women with axillary lymph node metastases only
* Women with peritoneal carcinomatosis only
* Well-differentiated neuroendocrine tumors
* Poorly differentiated tumors with midline tumor or elevated human chorionic gonadotropin (HCG)/alpha-fetoprotein (AFP)
* Men with adenocarcinoma and elevated prostate-specific antigen (PSA)
* Measurable disease
* No symptom emergency at the time of study entry including, but not limited to, the following:
* Back pain with epidural cord compression
* Large effusions causing distress
* Hypercalcemia
* Bowel obstruction
* Very painful (worst pain 10/10) solitary bone metastases with impending fracture
PATIENT CHARACTERISTICS:
* Modified "Physical Well-Being" subscale of the FACT-G score ≥ 6 within the past week
* Pain-intensity score ≥ 20 mm on the Memorial Pain Assessment Card OR receiving analgesics of ≥ 10 mg per day of oral morphine equivalent within the past week
* ECOG performance status 1-2
* WBC ≥ 3,000/mm³
* Platelet count ≥ 100,000/mm³
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to read, understand, and complete the quality of life and symptom questionnaires, and perception of change
* Able to complete the analgesic diary on a daily basis
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiation therapy
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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ECOG Group Chair's Office
Principal Investigators
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Victor T. Chang, MD
Role: STUDY_CHAIR
Veterans Affairs Medical Center - East Orange
Raymond S. Lord, MD
Role:
West Michigan Cancer Center
Locations
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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 Township, New Jersey, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The 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
Countries
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Other Identifiers
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ECOG-E5Z02
Identifier Type: -
Identifier Source: secondary_id
CDR0000486704
Identifier Type: -
Identifier Source: org_study_id