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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003744
First received: November 1, 1999
Last updated: January 17, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gemcitabine for Advanced Salivary Cancer: A Phase II Study

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Tumor Response Rate [ Time Frame: 2 Months ]

Secondary Outcome Measures:
  • Time to Progression [ Time Frame: 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 ]

Enrollment: 16
Study Start Date: November 1998
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Gemzar

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003744

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Harvard Pilgrim Health Care Institute
Boston, Massachusetts, United States, 02215
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Marshall R. Posner, MD
  More Information

Responsible Party: Robert I. Haddad, MD, Haddad, Robert MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00003744     History of Changes
Other Study ID Numbers: 98-168  P30CA006516  DFCI-98168  LILLY-DFCI-98168  NCI-G99-1496 
Study First Received: November 1, 1999
Last Updated: January 17, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Dana-Farber Cancer Institute:
stage III salivary gland cancer
stage IV salivary gland cancer
salivary gland squamous cell carcinoma
salivary gland acinic cell tumor
low-grade salivary gland mucoepidermoid carcinoma
high-grade salivary gland mucoepidermoid carcinoma
salivary gland adenocarcinoma
salivary gland poorly differentiated carcinoma
salivary gland anaplastic carcinoma
salivary gland malignant mixed cell type tumor
salivary gland adenoid cystic carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Salivary Gland Neoplasms
Neoplasms by Site
Neoplasms
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 24, 2017