Head and Neck CancerPhase 2NCT00003744
Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
A Phase 2 study testing gemcitabine in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 1998to May 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Harvard Pilgrim Health Care Institute
Boston, Massachusetts, 02215
Lahey Clinic
Burlington, Massachusetts, 01805
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: 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.
Read the 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.
.
- Conditions
- Head and Neck Cancer
- Being tested
- gemcitabine
- 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
- Medical subject headings
- Head and Neck Neoplasms, Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
Also called Gemzar
| Study group | Role | What they receive |
|---|---|---|
| Intercalcated Duct | Experimental | 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. Receives: Drug: gemcitabine |
| Excreatory Duct | Experimental | 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. Receives: Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate
Measured: 2 Months
Secondary outcomes (2)
Time to Progression
Measured: Interval from date of trial enrollment until documentation of PD or death or loss to follow-up
Number of Participants with Severe Adverse Events
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 1998
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Robert I. Haddad, MD, Dana-Farber Cancer Institute
- Investigators
- Marshall R. Posner, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003744
- Sponsor's protocol ID
- 98-168
- Other IDs
- P30CA006516, DFCI-98168, LILLY-DFCI-98168, NCI-G99-1496
- Status last verified
- Jan 2017
- First submitted
- 1 Nov 1999
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine for Advanced Salivary Cancer: A Phase II Study
- ClinicalTrials.gov ID
- NCT00003744
- Acronym / sponsor ID
- 98-168
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 1998
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercalcated Duct | Experimental | Drug: gemcitabineThe 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 | Experimental | Drug: gemcitabineThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabineAlso: Gemzar | Drug | Excreatory Duct, Intercalcated Duct |
Primary outcome
Tumor Response Rate
Time frame: 2 Months
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marshall R. Posner, MD study chair
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response Rate (time frame: 2 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.