Completed

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

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What is being tested

carboplatin

+ cisplatin
+ gemcitabine hydrochloride
Drug
Who is being recruted

Head and Neck Cancer

From 18 to 120 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003

Summary

Principal SponsorNCIC Clinical Trials Group
Last updated: August 4, 2023
Sourced from a government-validated database.Claim as a partner
Study start date: October 27, 2003Actual date on which the first participant was enrolled.

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). 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.

Official TitleA Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors 
Principal SponsorNCIC Clinical Trials Group
Last updated: August 4, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
34 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Head and Neck Cancer
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 4 locations
Suspended
CancerCare ManitobaWinnipeg, CanadaSee the location
Suspended
London Regional Cancer Program at London Health Sciences CentreLondon, Canada
Suspended
Ottawa Hospital Regional Cancer Centre - General CampusOttawa, Canada
Suspended
Princess Margaret HospitalToronto, Canada

Completed4 Study Centers