- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101075
Title XELOX FOR SALIVARY GLAND CANCERS
Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a study of two investigational agents called oxaliplatin and capecitabine.
Investigational agents have not received Food and Drug Administration (FDA) approval for the way they are being used in this study. This means an investigation drug is still under study to determine what a safe dose is, what the side effects are and whether or not it is effective in the disease or condition being studied.
Oxaliplatin and capecitabine are chemotherapy agents that have been approved by the FDA for use in other cancers.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 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. Attempts should be made to photo document all tumor sites assessed by physical examination with a metric ruler within the photo for measurement confirmation.
- Patients must be willing and able to go through the process of informed consent.
- 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/di 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.
- Subjects (male or female) must agree to use effective methods of birth control while on study.
- Subjects should be able to tolerate and swallow tablets or undergo GI tube insertion.
Exclusion Criteria
- Patients must have not received cytotoxic chemotherapy for metastatic 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. Patients may have received chemotherapy given concomitantly with radiation therapy in an adjuvant setting with curative intent.
- Patients must not receive any form (including radiotherapeutic, immunologic, hormonal,homeopathic, natural, or alternative medicine) of anti-neoplastic therapy other than XELOX 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) are not eligible for this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: XELOX
|
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment
Time Frame: Every 2 Cycles
|
Every 2 Cycles
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment
Time Frame: Every 2 Cycles
|
Every 2 Cycles
|
Toxicity as assessed by CTCAE weekly
Time Frame: Weekly
|
Weekly
|
Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3
Time Frame: Baseline andDay 3
|
Baseline andDay 3
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert I. Haddad, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV 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 squamous cell carcinoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-149
- P30CA006516 (U.S. NIH Grant/Contract)
- SANOFI-DFCI-04149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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