Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments capecitabine, oxaliplatin
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date October 2004
Trial size 33 participants
Trial identifier NCT00101075, CDR0000406025, DFCI-04149, SANOFI-DFCI-04149

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment
time frame:

Secondary Outcomes

Measure
Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment
time frame:
Toxicity as assessed by CTCAE weekly
time frame:
Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).