Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery

January 17, 2017 updated by: Robert I. Haddad, MD, Dana-Farber Cancer Institute

Gemcitabine for Advanced Salivary Cancer: A Phase II Study

The purpose of this study is to see how patients with incurable salivary gland cancer, who have not had chemotherapy before, respond to Gemcitabine. The investigators are trying to find out what effects (good and bad) Gemcitabine has on participants and salivary gland cancer.

Gemcitabine has been shown to be an effective chemotherapy agent in other types of cancer, including; bladder cancer, breast cancer, certain types of lung cancer, ovarian cancer, and pancreas cancer. Gemcitabine has yet to be studied for efficacy in subjects with salivary gland cancer and in general other chemotherapy drugs have shown to be ineffective so far in this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

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Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Harvard Pilgrim Health Care Institute
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Inclusion Criteria:

  • Histologic diagnosis of any of the following malignancies originating from salivary tissue: adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinoma, malignant mixed tumor, polymorphous low grade adenocarcinoma, undifferentiated carcinoma, squamous cell carcinoma, adenocarcinoma.
  • Patients must be incurable on the basis of unresectable local or distant disease as determined by the patient's surgeon and not be potentially curable by radiation therapy as determined by a radiation oncologist.
  • Patients may have received radiation to any site with the following caveat: the sites used for evaluation for response are either not previously irradiated or they have shown progression of disease post radiation and there has been a time interval of one month since these sites were radiated.
  • Patients must have an ECOG performance status of less than 3.
  • Patients must have at least uni-dimensionally measurable disease documented within one month of initiation of treatment. Measurement may be by physical exam or radiologically.
  • Patients must be willing and able to go through the process of informed consent.
  • Patients must have a life expectancy exceeding 3 months.
  • Patients must be at least 18 years old.

  • Patients must have adequate organ function as defined by the following tests to be performed within 14 days of therapy initiation:

    • Absolute neutrophil count > 1999 cells x 10 6/L
    • Platelet count > 99,999 cells x 10 6/L
    • Hemoglobin >8.5 gm/dl or HCT > 25%
    • Serum creatinine < 1.5 x institutional upper limits of normal (ULN) or creatinine clearance measured by 24 hour urine collection as at least 50% of institutional lower limit of normal.
    • Total bilirubin <2 x institutional ULN

    • AST (SGOT) <2 x institutional ULN *

      ---*If from documented liver involvement with cancer, may be up to < 5 x institutional ULN

    • Alkaline Phosphatase < 5 x institutional ULN --- If from documented bone or liver involvement with cancer, no upper limit restriction.

Exclusion Criteria

  • Patients must have not received cytotoxic chemotherapy for salivary gland cancer.
  • 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 receive any form (including radiotherapeutic, immunologic, hormonal, homeopathic, natural, or alternative medicine) of anti-neoplastic therapy other than gemcitabine while participating in this study.
  • 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.
  • Patients with significant active illness (e.g. congestive heart failure, COPD, uncontrolled diabetes, AIDS) are not eligible for this study.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intercalcated Duct

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.
Drug: gemcitabine
Other Names:
  • Gemzar
EXPERIMENTAL: Excreatory Duct

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.
Drug: gemcitabine
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor Response Rate
Time Frame: 2 Months
2 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Progression
Time Frame: Interval from date of trial enrollment until documentation of PD or death or loss to follow-up
Interval from date of trial enrollment until documentation of PD or death or loss to follow-up
Number of Participants with Severe Adverse Events
Time Frame: 2 Months
2 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Marshall R. Posner, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Primary Completion (ACTUAL)

May 1, 2004

Study Completion (ACTUAL)

May 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-168
  • P30CA006516 (U.S. NIH Grant/Contract)
  • DFCI-98168
  • LILLY-DFCI-98168
  • NCI-G99-1496

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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