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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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.

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response measured by RECIST criteria after accrual of 11 evaluable patients

Secondary outcomes (2)
  1. Toxicity assessed by NCI CTC v2.0

  2. Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2004 (estimated)
  2. Study start27 Oct 2003
  3. Primary completion29 Sep 2008
  4. Study completion10 Feb 2009

Resources

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)
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

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.

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