Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Salivary Gland Cancer That Cannot Be Removed By Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00101075
First received: January 7, 2005
Last updated: July 23, 2008
Last verified: November 2006

January 7, 2005
July 23, 2008
October 2004
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Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00101075 on ClinicalTrials.gov Archive Site
  • Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment [ Designated as safety issue: No ]
  • Toxicity as assessed by CTCAE weekly [ Designated as safety issue: Yes ]
  • Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3 [ Designated as safety issue: No ]
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Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Salivary Gland Cancer That Cannot Be Removed By Surgery
Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine together with oxaliplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced or metastatic salivary gland cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

  • Determine the tumor response rate in patients with unresectable locally advanced or metastatic incurable salivary gland cancer treated with capecitabine and oxaliplatin.

Secondary

  • Determine time to disease progression in patients treated with this regimen.
  • Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a nonrandomized study.

Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a positive response after 2 courses receive additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of treatment beyond CR.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: capecitabine
  • Drug: oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
33
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DISEASE CHARACTERISTICS:

  • Histologically confirmed salivary gland cancer, including the following histologies:

    • Adenoid cystic carcinoma
    • Mucoepidermoid carcinoma
    • Acinic cell carcinoma
    • Malignant mixed tumor
    • Polymorphous low-grade adenocarcinoma
    • Undifferentiated carcinoma
    • Squamous cell carcinoma
    • Adenocarcinoma
  • Incurable disease

    • Unresectable local or distant disease
  • At least 1 unidimensionally measurable lesion documented by physical exam or radiology within the past month

    • No prior radiotherapy to sites used for evaluation of response unless these sites demonstrate disease progression after completion of radiotherapy
  • Not amenable to potentially curative radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin > 8.5 g/dL
  • Hematocrit > 25%

Hepatic

  • Bilirubin < 2 times upper limit of normal (ULN)
  • AST < 2 times ULN (5 times ULN with liver involvement)
  • Alkaline phosphatase < 5 times ULN (no upper limit restriction with bone or liver involvement)

Renal

  • Creatinine < 1.5 times ULN OR
  • Creatinine clearance ≥ 50% of lower limit of normal on 24-hour urine collection

Cardiovascular

  • No congestive heart failure

Pulmonary

  • No chronic obstructive pulmonary disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • Able to tolerate and swallow tablets OR undergo gastrointestinal tube insertion
  • No uncontrolled diabetes
  • No other significant active illness
  • No other invasive malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or cervical cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 28 days since prior and no concurrent immunotherapy

Chemotherapy

  • Prior adjuvant chemotherapy given with radiotherapy with curative intent allowed
  • No prior cytotoxic chemotherapy for metastatic salivary gland cancer

Endocrine therapy

  • More than 28 days since prior and no concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • See Chemotherapy
  • More than 1 month since prior radiotherapy to sites used for evaluation of response
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • More than 28 days since prior and no concurrent homeopathic therapy
  • More than 28 days since prior and no concurrent natural therapy
  • More than 28 days since prior and no concurrent alternative medicine therapy
  • No other concurrent anticancer therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00101075
CDR0000406025, DFCI-04149, SANOFI-DFCI-04149
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Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Robert I. Haddad, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP