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Phase II Protocol: Gemcitabine for Metastatic Cancer With Unknown Primary Site - Analysis of Symptom Benefit

Phase 2
18 Years
Not Enrolling
Carcinoma of Unknown Primary, Pain

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Trial Information

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
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.

Inclusion Criteria


- Histologically confirmed poorly differentiated carcinoma or adenocarcinoma of unknown

- 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

- 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


- 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


- No prior chemotherapy or radiation therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

Victor T. Chang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Veterans Affairs Medical Center - East Orange


United States: Federal Government

Study ID:




Start Date:

June 2006

Completion Date:

Related Keywords:

  • Carcinoma of Unknown Primary
  • Pain
  • adenocarcinoma of unknown primary
  • newly diagnosed carcinoma of unknown primary
  • undifferentiated carcinoma of unknown primary
  • pain
  • Carcinoma
  • Neoplasm Metastasis
  • Neoplasms, Unknown Primary



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