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Carcinoma of Unknown PrimaryPhase 2NCT00357630

Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary

A Phase 2 study testing gemcitabine hydrochloride and quality-of-life assessment in people with Carcinoma of Unknown Primary and Pain, run by Eastern Cooperative Oncology Group at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Carcinoma of Unknown Primary, Pain
What is being tested?
gemcitabine hydrochloride and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
52 participants
Where
37 sitesUnited States
Study dates
Jun 2006to Feb 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Our Lady of Mercy Medical Center Comprehensive Cancer Center

    The Bronx, New York, 10466

  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey

    Voorhees Township, New Jersey, 08043

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
gemcitabine hydrochloride, quality-of-life assessment
Keywords
adenocarcinoma of unknown primary, newly diagnosed carcinoma of unknown primary, undifferentiated carcinoma of unknown primary, pain
Medical subject headings
Neoplasms, Unknown Primary, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

  1. Changes in symptom distress, pain, and quality of life at 8, 16, and 32 weeks

  2. Tumor response and duration

  3. Survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00357630
Sponsor's protocol ID
CDR0000486704
Other IDs
ECOG-E5Z02
Status last verified
Oct 2008
First submitted
26 Jul 2006
Last updated
2 Nov 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and quality-of-life assessment in people with Carcinoma of Unknown Primary and Pain, run by Eastern Cooperative Oncology Group at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy, in terms of improved quality of life and reduction of symptom distress. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00357630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.

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