Completed

Gemcitabine for Advanced Salivary Cancer: A Phase II Study

What is being tested

gemcitabine

+ gemcitabine

Drug

Who is being recruted

Stomatognathic Diseases+5

+ Mouth Diseases

+ Mouth Neoplasms

Over 18 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: November 1998

See protocol details

Summary

Principal SponsorDana-Farber Cancer Institute

Last updated: January 19, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1998

Actual date on which the first participant was enrolled.

OBJECTIVES: Evaluate the response rate of patients with incurable salivary gland cancer treated with gemcitabine. Evaluate the time to progression and toxicity of this therapy in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV for 30 minutes on days 1, 8, and 15 of each 28 day course. Patients receive a minimum of 2 courses of treatment. Patients may continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. .

NCT00003744

Principal SponsorDana-Farber Cancer Institute

Last updated: January 19, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Stomatognathic DiseasesMouth DiseasesMouth NeoplasmsNeoplasmsNeoplasms by SiteSalivary Gland DiseasesHead and Neck NeoplasmsSalivary Gland Neoplasms

Criteria

6 exclusion criteria prevent from participating

Patients with significant active illness (e.g. congestive heart failure, COPD, uncontrolled diabetes, AIDS) are not eligible for this study.

Previous immunologic, hormonal, homeopathic, natural, or alternative medicine therapies are acceptable provided treatment ended greater than 28 days prior to protocol therapy. Previous radiotherapy for salivary cancer is acceptable provided treatment ended greater than 28 days prior to protocol therapy.

Patients must not have a history of any invasive neoplasm within three years of trial entry, excepting curatively treated non-melanoma skin cancer and cervical cancer.

Pregnant and breast feeding women are not eligible for this study. No pregnancy test is required. Women of childbearing potential must be counseled on the use of effective birth control prior to participation in this study.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

The first group, referred to as intercalated duct will include Aadenoid cystic carcinoma, acinic cell carcinoma, malignant mixed tumor, polymorphous low grade adenocarcinoma, undifferentiated carcinoma, and adenocarcinoma. - Gemcitabine iv 30 min infusion on days 1,8, and 15 of each 28 day cycle. -- Participants will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.

Group II

Experimental

The second group, referred to as excretory duct, will include: squamous cell carcinoma and mucoepidermoid carcinoma. Gemcitabine iv 30 min infusion on days 1,8, and 15 of each 28 day cycle. Participants will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

University of Chicago Cancer Research Center

Chicago, United StatesOpen University of Chicago Cancer Research Center in Google Maps

Massachusetts General Hospital

Boston, United States

Dana Farber Cancer Institute

Boston, United States

Harvard Pilgrim Health Care Institute

Boston, United States

Completed6 Study Centers