NCT00101075

Brief Summary

The goal of this clinical research study is to find out how effective oxaliplatin and capecitabine are against advanced cancer of the salivary gland. The safety of this treatment as well as how long the cancer responds or stays in a stable state due to the treatment will also be studied.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

2.4 years

First QC Date

January 7, 2005

Last Update Submit

February 24, 2017

Conditions

Head and Neck Cancer

Keywords

high-grade salivary gland mucoepidermoid carcinomalow-grade salivary gland mucoepidermoid carcinomasalivary gland acinic cell tumorsalivary gland adenocarcinomasalivary gland adenoid cystic carcinomasalivary gland malignant mixed cell type tumorsalivary gland poorly differentiated carcinomasalivary gland squamous cell carcinomarecurrent salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment

    Every 2 Cycles

Secondary Outcomes (3)

  • Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment

    Every 2 Cycles

  • Toxicity as assessed by CTCAE weekly

    Weekly

  • Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3

    Baseline andDay 3

Study Arms (1)

XELOX

EXPERIMENTAL

* Oxaliplatin 130 mg/m2 day 1 every 3 weeks * Capecitabine 1700 mg/m2/day days 1-14 every 3 weeks. -- Patients will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.

Drug: CapecitabineDrug: Oxaliplatin

Interventions

CapecitabineDRUG
Also known as: Xeloda
XELOX
OxaliplatinDRUG
Also known as: Eloxatin
XELOX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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\*
  • +4 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSalivary Gland Neoplasms

Interventions

CapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Study Officials

  • Robert I. Haddad, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2005

First Posted

January 10, 2005

Study Start

October 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2008

Last Updated

February 27, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)