Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary - Full Text View

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00357630

Purpose

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	Intervention	Phase
Carcinoma of Unknown Primary Pain	Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Protocol: Gemcitabine for Metastatic Cancer With Unknown Primary Site - Analysis of Symptom Benefit

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy, in terms of improved quality of life and reduction of symptom distress [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in symptom distress, pain, and quality of life at 8, 16, and 32 weeks [ Designated as safety issue: No ]
Tumor response and duration [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	June 2006
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357630

Show 37 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Victor T. Chang, MD	Veterans Affairs Medical Center - East Orange
Investigator:	Raymond S. Lord, MD	West Michigan Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	ECOG Group Chair's Office ( Robert L. Comis )
Study ID Numbers:	CDR0000486704, ECOG-E5Z02
Study First Received:	July 26, 2006
Last Updated:	April 11, 2009
ClinicalTrials.gov Identifier:	NCT00357630 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of unknown primary
newly diagnosed carcinoma of unknown primary
undifferentiated carcinoma of unknown primary
pain

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Neoplasms, Unknown Primary
Immunologic Factors
Pain
Antiviral Agents
Immunosuppressive Agents

Carcinoma
Radiation-Sensitizing Agents
Neoplasm Metastasis
Adenocarcinoma
Gemcitabine
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms, Unknown Primary
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplastic Processes
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Neoplasm Metastasis
Gemcitabine
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009