Clinical Trials Logo
  1. Home
  2. Pain
  3. NCT00357630
  4. Details
NCT00357630 Clinical Trial

Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00357630
Other study ID # CDR0000486704
Secondary ID ECOG-E5Z02
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2006

Study information
Verified date October 2008
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• gemcitabine hydrochloride

Procedure:
• quality-of-life assessment

Locations
Country Name City State
United States McFarland Clinic, PC Ames Iowa
United States Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx New York
United States Mercy Cancer Center at Mercy Medical Center Canton Ohio
United States University of Illinois Cancer Center Chicago Illinois
United States Veterans Affairs Medical Center - Chicago Westside Hospital Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Case Comprehensive Cancer Center Cleveland Ohio
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Medical Center Cancer Care Columbus Ohio
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States Decatur Memorial Hospital Cancer Care Institute Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
United States Elkhart General Hospital Elkhart Indiana
United States Hinsdale Hematology Oncology Associates Hinsdale Illinois
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Howard Community Hospital Kokomo Indiana
United States Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Fairfield Medical Center Lancaster Ohio
United States St. Rita's Medical Center Lima Ohio
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton New Jersey
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Saint Joseph Regional Medical Center South Bend Indiana
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Mercy Medical Center Springfield Ohio
United States Regional Cancer Center at Memorial Medical Center Springfield Illinois
United States Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (2)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy, in terms of improved quality of life and reduction of symptom distress
Secondary Changes in symptom distress, pain, and quality of life at 8, 16, and 32 weeks
Secondary Tumor response and duration
Secondary Survival
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Recruiting NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care