Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
Gemcitabine for Advanced Salivary Cancer: A Phase II Study
5 other identifiers
interventional
16
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 head-and-neck-cancer
Started Nov 1998
Typical duration for phase_2 head-and-neck-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedJanuary 19, 2017
January 1, 2017
5.5 years
November 1, 1999
January 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor Response Rate
2 Months
Secondary Outcomes (2)
Time to Progression
Interval from date of trial enrollment until documentation of PD or death or loss to follow-up
Number of Participants with Severe Adverse Events
2 Months
Study Arms (2)
Intercalcated Duct
EXPERIMENTALThe 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.
Excreatory Duct
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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 \*
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (6)
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Harvard Pilgrim Health Care Institute
Boston, Massachusetts, 02215, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marshall R. Posner, MD
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Haddad, Robert MD
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
November 1, 1998
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
January 19, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share