Gemcitabine hydrochloride and quality-of-life assessment in Pain and Carcinoma of Unknown Primary - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Chicago, Illinois, United States, 60612-7243
    - University of Illinois Cancer Center
  - Chicago, Illinois, United States, 60612
    - Veterans Affairs Medical Center - Chicago Westside Hospital
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Hinsdale, Illinois, United States, 60521
    - Hinsdale Hematology Oncology Associates
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
- Indiana
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, United States, 46617
    - Saint Joseph Regional Medical Center
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
- Michigan
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
- New Jersey
  - Marlton, New Jersey, United States, 08053
    - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  - Voorhees, New Jersey, United States, 08043
    - Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- New York
  - Bronx, New York, United States, 10466
    - Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Ohio
  - Canton, Ohio, United States, 44708
    - Mercy Cancer Center at Mercy Medical Center
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cleveland, Ohio, United States, 44106-5065
    - Case Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45801
    - St. Rita's Medical Center
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, United States, 45504
    - Mercy Medical Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Wisconsin
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Victor T. Chang, MD, Veterans Affairs Medical Center - East Orange
Raymond S. Lord, MD, West Michigan Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

July 26, 2006

First Submitted That Met QC Criteria