Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Salivary Gland Cancer That Cannot Be Removed By Surgery
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: capecitabine Drug: oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers |
- Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 33 |
| Study Start Date: | October 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Study Chair: | Robert I. Haddad, MD | Dana-Farber Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00101075 History of Changes |
| Other Study ID Numbers: | CDR0000406025, DFCI-04149, SANOFI-DFCI-04149 |
| Study First Received: | January 7, 2005 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
high-grade salivary gland mucoepidermoid carcinoma low-grade salivary gland mucoepidermoid carcinoma salivary gland acinic cell tumor salivary gland adenocarcinoma salivary gland adenoid cystic carcinoma salivary gland malignant mixed cell type tumor |
salivary gland poorly differentiated carcinoma salivary gland squamous cell carcinoma recurrent salivary gland cancer stage III salivary gland cancer stage IV salivary gland cancer |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Salivary Gland Neoplasms Neoplasms by Site Neoplasms Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Oxaliplatin Capecitabine |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013