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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago Cancer Research Center
  • Massachusetts General Hospital
  • Dana Farber Cancer Institute
  • Harvard Pilgrim Health Care Institute
  • Lahey Clinic
  • Sarah Cannon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intercalcated Duct

Excreatory Duct

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tumor Response Rate

Secondary Outcome Measures

Time to Progression
Number of Participants with Severe Adverse Events

Full Information

First Posted
November 1, 1999
Last Updated
January 17, 2017
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003744
Brief Title
Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
Official Title
Gemcitabine for Advanced Salivary Cancer: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intercalcated Duct
Arm Type
Experimental
Arm Description
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.
Arm Title
Excreatory Duct
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
Gemzar
Primary Outcome Measure Information:
Title
Tumor Response Rate
Time Frame
2 Months
Secondary Outcome Measure Information:
Title
Time to Progression
Time Frame
Interval from date of trial enrollment until documentation of PD or death or loss to follow-up
Title
Number of Participants with Severe Adverse Events
Time Frame
2 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall R. Posner, MD
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Harvard Pilgrim Health Care Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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