Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00357630

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

1.4

Patients Per Site

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in symptom distress, pain, and quality of life at 8, 16, and 32 weeks []
Tumor response and duration []
Survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
2	Veterans Affairs Medical Center - Chicago Westside Hospital	Chicago	Illinois	United States	60612
3	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
4	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
5	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
6	Elkhart General Hospital	Elkhart	Indiana	United States	46515
7	Howard Community Hospital	Kokomo	Indiana	United States	46904
8	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
9	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
10	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
11	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
12	McFarland Clinic, PC	Ames	Iowa	United States	50010
13	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
14	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
15	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
16	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
17	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey	United States	08053
18	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey	United States	08043
19	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York	United States	10466
20	Mercy Cancer Center at Mercy Medical Center	Canton	Ohio	United States	44708
21	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
22	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
23	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
24	CCOP - Columbus	Columbus	Ohio	United States	43215
25	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
26	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
27	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
28	Grady Memorial Hospital	Delaware	Ohio	United States	43015
29	Fairfield Medical Center	Lancaster	Ohio	United States	43130
30	St. Rita's Medical Center	Lima	Ohio	United States	45801
31	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
32	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
33	Mercy Medical Center	Springfield	Ohio	United States	45504
34	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
35	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
36	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
37	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601