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

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ClinicalTrials.gov Identifier: NCT00003744
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 19, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date January 19, 2017
Study Start Date  ICMJE November 1998
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
Tumor Response Rate [ Time Frame: 2 Months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
Official Title  ICMJE Gemcitabine for Advanced Salivary Cancer: A Phase II Study
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.

.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Drug: gemcitabine
Other Name: Gemzar
Study Arms  ICMJE
  • 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.

    Intervention: Drug: gemcitabine
  • 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.
    Intervention: Drug: gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2017)
16
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2004
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003744
Other Study ID Numbers  ICMJE 98-168
P30CA006516 ( U.S. NIH Grant/Contract )
DFCI-98168
LILLY-DFCI-98168
NCI-G99-1496
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert I. Haddad, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Marshall R. Posner, MD
PRS Account Dana-Farber Cancer Institute
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP