Head and Neck CancerPhase 2NCT00079079
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor
A Phase 2 study testing carboplatin, cisplatin and gemcitabine hydrochloride in people with Head and Neck Cancer, run by NCIC Clinical Trials Group at 4 sites in Canada.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- carboplatin, cisplatin and gemcitabine hydrochloride
- How many people
- 34 participants
- Where
- 4 sitesCanada
- Study dates
- 27 Oct 2003to 10 Feb 2009
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant salivary gland tumor
- All histological subtypes eligible
- Locally advanced, recurrent, or metastatic disease
- Considered incurable by radiotherapy or surgery
- Low- to intermediate-grade mucoepidermoid tumor or acinic cell carcinoma allowed provided patients are symptomatic OR at imminent risk of developing symptoms attributable to metastatic disease
- Disease must meet 1 of the following criteria:
- Metastatic disease that is chemonaïve
- Metastatic disease that has progressed after a prior non-cisplatin/carboplatin/gemcitabine regimen
- Local and/or distant recurrence after curative surgery and/or radiotherapy
- Locally advanced disease not suitable for surgery or radiotherapy
- At least 1 site of unidimensionally measurable disease documented by 1 of the following:
- At least 20 mm by X-ray, physical exam, or non-spiral CT scan
- At least 10 mm by spiral CT scan
- No bone metastases as only site of measurable disease
- No known brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- AST/ALT no greater than 3 times upper limit of normal
Renal
- Creatinine clearance at least 60 mL/min (for cisplatin) OR 30-59 mL/min (for carboplatin)
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious illness or medical condition that would preclude study participation
- No active uncontrolled infection
- No neurologic disorder or psychiatric illness that would preclude study compliance
- No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy for locally advanced, recurrent, or metastatic disease and recovered
- Must have been a non-cisplatin/carboplatin/gemcitabine-containing regimen
- More than 12 months since prior adjuvant chemotherapy (including cisplatin/carboplatin-based regimens) and recovered
- No prior gemcitabine
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to only site of measurable disease unless there is documented disease progression after therapy
Surgery
- See Disease Characteristics
- At least 21 days since prior surgery and recovered
Other
- More than 30 days since prior anticancer therapy
- More than 30 days since prior investigational agents
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors
RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with either cisplatin or carboplatin works in treating patients with locally advanced, recurrent, or metastatic malignant salivary gland tumor (cancer).
Read the detailed description
OBJECTIVES:
Primary
- Determine the activity of cisplatin or carboplatin in combination with gemcitabine, in terms of response rate, in patients with locally advanced, recurrent, or metastatic malignant salivary gland tumor.
Secondary
- Determine the complete response in patients treated with these regimens.
- Determine the duration of response in patients treated with these regimens.
- Determine the toxicity profile of these regimens in these patients.
- Determine the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive either cisplatin IV over 1 hour on day 2 OR carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months thereafter until relapse.
PROJECTED ACCRUAL: A total of 11- 34 patients will be accrued for this study within 1.5-3 years.
- Conditions
- Head and Neck Cancer
- Being tested
- carboplatin, cisplatin, gemcitabine hydrochloride
- Keywords
- stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, salivary gland acinic cell tumor, salivary gland adenoid cystic carcinoma, salivary gland poorly differentiated carcinoma, high-grade salivary gland mucoepidermoid carcinoma, low-grade salivary gland mucoepidermoid carcinoma, salivary gland malignant mixed cell type tumor, salivary gland adenocarcinoma, salivary gland anaplastic carcinoma, salivary gland squamous cell 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.
carboplatinDrug
cisplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response measured by RECIST criteria after accrual of 11 evaluable patients
Secondary outcomes (2)
Toxicity assessed by NCI CTC v2.0
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2004 (estimated)
- Study start27 Oct 2003
- Primary completion29 Sep 2008
- Study completion10 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Lillian L. Siu, MD, FRCPC, Study chair, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079079
- Sponsor's protocol ID
- HN4
- Other IDs
- CAN-NCIC-HN4, LILLY-CAN-NCIC-HN4, CDR0000353487
- Status last verified
- Apr 2020
- First submitted
- 8 Mar 2004
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laurie SA, Siu LL, Winquist E, Maksymiuk A, Harnett EL, Walsh W, Tu D, Parulekar WR. A phase 2 study of platinum and gemcitabine in patients with advanced salivary gland cancer: a trial of the NCIC Clinical Trials Group. Cancer. 2010 Jan 15;116(2):362-8. doi: 10.1002/cncr.24745.
PubMed 19924794
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors
- ClinicalTrials.gov ID
- NCT00079079
- Acronym / sponsor ID
- HN4
- Conditions
- Head and Neck Cancer
- Keywords
- stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, salivary gland acinic cell tumor, salivary gland adenoid cystic carcinoma, salivary gland poorly differentiated carcinoma, high-grade salivary gland mucoepidermoid carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 27 Oct 2003 (actual)
- Primary completion
- 29 Sep 2008 (actual)
- Study completion
- 10 Feb 2009 (actual)
- First posted
- 9 Mar 2004 (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.
RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with either cisplatin or carboplatin works in treating patients with locally advanced, recurrent, or metastatic malignant salivary gland tumor (cancer).
Detailed description
OBJECTIVES:
Primary
- Determine the activity of cisplatin or carboplatin in combination with gemcitabine, in terms of response rate, in patients with locally advanced, recurrent, or metastatic malignant salivary gland tumor.
Secondary
- Determine the complete response in patients treated with these regimens.
- Determine the duration of response in patients treated with these regimens.
- Determine the toxicity profile of these regimens in these patients.
- Determine the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive either cisplatin IV over 1 hour on day 2 OR carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months thereafter until relapse.
PROJECTED ACCRUAL: A total of 11- 34 patients will be accrued for this study within 1.5-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| gemcitabine hydrochloride | Drug | – |
Primary outcome
Objective response measured by RECIST criteria after accrual of 11 evaluable patients
2 secondary outcomes
Toxicity assessed by NCI CTC v2.0
Overall survival
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 4 Aug 2023.
- Results publication: PubMed 19924794Laurie SA, Siu LL, Winquist E, Maksymiuk A, Harnett EL, Walsh W, Tu D, Parulekar WR. A phase 2 study of platinum and gemcitabine in patients with advanced salivary gland cancer: a trial of the NCIC Clinical Trials Group. Cancer. 2010 Jan 15;116(2):362-8. doi: 10.1002/cncr.24745.
- 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.
Lillian L. Siu, MD, FRCPC study chair
Princess Margaret Hospital, Canada
4 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 carboplatin, cisplatin and gemcitabine hydrochloride in people with Head and Neck Cancer, run by NCIC Clinical Trials Group at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Objective response measured by RECIST criteria after accrual of 11 evaluable patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00079079, which also lists 1 linked publication.
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 4 Aug 2023.