Trial record 4 of 72 for:    "Salivary Gland Neoplasms"

Cisplatin or Carboplatin Combined With Gemcitabine in Treating Patients With Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00079079
First received: March 8, 2004
Last updated: November 7, 2010
Last verified: March 2010
  Purpose

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).


Condition Intervention Phase
Head and Neck Cancer
Drug: carboplatin
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Objective response measured by RECIST criteria after accrual of 11 evaluable patients [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity assessed by NCI CTC v2.0 [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: October 2003
Study Completion Date: February 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079079

Locations
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Lillian L. Siu, MD, FRCPC Princess Margaret Hospital, Canada
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00079079     History of Changes
Other Study ID Numbers: HN4, CAN-NCIC-HN4, LILLY-CAN-NCIC-HN4, CDR0000353487
Study First Received: March 8, 2004
Last Updated: November 7, 2010
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
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

Additional relevant MeSH terms:
Salivary Gland Neoplasms
Head and Neck Neoplasms
Mouth Diseases
Mouth Neoplasms
Neoplasms
Neoplasms by Site
Salivary Gland Diseases
Stomatognathic Diseases
Carboplatin
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014