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Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary

Primary Purpose

Carcinoma of Unknown Primary, Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
quality-of-life assessment
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring adenocarcinoma of unknown primary, newly diagnosed carcinoma of unknown primary, undifferentiated carcinoma of unknown primary, pain

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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

Sites / Locations

  • University of Illinois Cancer Center
  • Veterans Affairs Medical Center - Chicago Westside Hospital
  • Decatur Memorial Hospital Cancer Care Institute
  • Hinsdale Hematology Oncology Associates
  • Regional Cancer Center at Memorial Medical Center
  • Elkhart General Hospital
  • Howard Community Hospital
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Saint Joseph Regional Medical Center
  • McFarland Clinic, PC
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • Lakeland Regional Cancer Care Center - St. Joseph
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • Mercy Cancer Center at Mercy Medical Center
  • Adena Regional Medical Center
  • Case Comprehensive Cancer Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Medical Center Cancer Care
  • Mount Carmel Health - West Hospital
  • Doctors Hospital at Ohio Health
  • Grady Memorial Hospital
  • Fairfield Medical Center
  • St. Rita's Medical Center
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Mercy Medical Center
  • Community Hospital of Springfield and Clark County
  • Mount Carmel St. Ann's Cancer Center
  • Genesis - Good Samaritan Hospital
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

Outcomes

Primary Outcome Measures

Efficacy, in terms of improved quality of life and reduction of symptom distress

Secondary Outcome Measures

Changes in symptom distress, pain, and quality of life at 8, 16, and 32 weeks
Tumor response and duration
Survival

Full Information

First Posted
July 26, 2006
Last Updated
October 29, 2020
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00357630
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 Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of Unknown Primary, Pain
Keywords
adenocarcinoma of unknown primary, newly diagnosed carcinoma of unknown primary, undifferentiated carcinoma of unknown primary, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Efficacy, in terms of improved quality of life and reduction of symptom distress
Secondary Outcome Measure Information:
Title
Changes in symptom distress, pain, and quality of life at 8, 16, and 32 weeks
Title
Tumor response and duration
Title
Survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor T. Chang, MD
Organizational Affiliation
Veterans Affairs Medical Center - East Orange
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Raymond S. Lord, MD
Organizational Affiliation
West Michigan Cancer Center
Facility Information:
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7243
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago Westside Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Hinsdale Hematology Oncology Associates
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
McFarland Clinic, PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Medical Center Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
St. Rita's Medical Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Mercy Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Mount Carmel St. Ann's Cancer Center
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

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Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary

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