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
• Start date: June 2006

Study information

• Verified date: October 2008
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• 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. 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma of Unknown Primary
• Neoplasm Metastasis
• Neoplasms, Unknown Primary
• Pain

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