Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00357630
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : April 14, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Carcinoma of Unknown Primary Pain Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Estimated Enrollment : 52 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Protocol: Gemcitabine for Metastatic Cancer With Unknown Primary Site - Analysis of Symptom Benefit
Study Start Date : June 2006
Actual Primary Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Efficacy, in terms of improved quality of life and reduction of symptom distress

Secondary Outcome Measures :
  1. Changes in symptom distress, pain, and quality of life at 8, 16, and 32 weeks
  2. Tumor response and duration
  3. Survival

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00357630

  Show 37 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Victor T. Chang, MD Veterans Affairs Medical Center - East Orange
OverallOfficial: Raymond S. Lord, MD West Michigan Cancer Center

Responsible Party: Robert L. Comis, ECOG Group Chair's Office Identifier: NCT00357630     History of Changes
Other Study ID Numbers: CDR0000486704
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: April 14, 2009
Last Verified: October 2008

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of unknown primary
newly diagnosed carcinoma of unknown primary
undifferentiated carcinoma of unknown primary

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs