View Clinical Trial (Medical Research Study)
A Pilot Study to Evaluate Response to Neoadjuvant Chemotherapy With Cisplatin and Docetaxel Followed by Chemoradiation Therapy With Carboplatin in Stage IV Non-metastatic Head and Neck Cancer
| City: |
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Colchester |
| State: |
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Vermont |
| Zip Code: |
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05446 |
| Conditions: |
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Head and Neck Neoplasms |
| Purpose: |
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The purpose of this study is to evaluate the effectiveness and safety of neoadjuvant
chemotherapy (chemotherapy given before radiotherapy) using cisplatin and docetaxel,
followed by carboplatin given at the same time as radiotherapy in the treatment of locally
advanced head and neck cancer.
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| Study Summary: |
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Chemoradiotherapy has become the standard of care for patients with unresectable head and
neck cancer, but there can be substantial added toxicity with chemoradiotherapy compared to
radiation therapy alone. Neoadjuvant therapy with cisplatin / 5-fluorouracil has
demonstrated activity in this disease, and taxanes appear to improve response further.
Docetaxel / cisplatin / 5-fluorouracil has been shown to be a highly active regimen.
However, with the potential added toxicities of neoadjuvant chemotherapy, it is important to
minimize toxicity while maintaining efficacy. Chemotherapeutic agents that are DNA
cycle-specific like 5-fluorouracil are more stomatotoxic than those that are cell phase
non-specific. Of note, several studies have suggested that docetaxel and cisplatin is a
highly active combination when used for advanced disease or as neoadjuvant therapy .
This study will therefore test the efficacy of neoadjuvant chemotherapy with cisplatin and
docetaxel without 5-fluorouracil followed by chemoradiotherapy with carboplatin to determine
whether promising response rates with modest toxicity can be achieved. Carboplatin will be
used as the radiosensitizing agent during chemoradiotherapy to reduce nephrotoxicity and
neurotoxicity as compared to further treatment with cisplatin.
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| Criteria: |
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Inclusion Criteria:
- Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral
cavity, larynx, oropharynx or hypopharynx
- Measurable or evaluable disease
- No distant metastases
- Tumor should be surgically unresectable for cure or resection is considered
inadvisable
- Age > 18 years
- ECOG performance status 0, 1 or 2
- Life expectancy > 2 months
- Patients must have adequate organ and marrow function as defined below:
- Leukocytes > 3,000/mm3
- Absolute neutrophil count > 1,500/mm3
- Platelets > 100,000/mm3
- Hemoglobin > 10.0g/dL
- Total Bilirubin <= institutional upper limit of normal
- Aspartate aminotransferase < 2.5 X institutional upper limit of normal
- Alanine aminotransferase < 2.5 X institutional upper limit of normal
- Alkaline phosphatase < 2.5 X institutional upper limit of normal
- Creatinine <= institutional upper limit of normal OR creatinine clearance > 60
mL/min/1.73 m2 for patients with creatinine > institutional upper limit of
normal
- Signed informed consent
- Women of child-bearing potential and men must be willing and able practice adequate
contraception prior to study entry and for the duration of study treatment
Exclusion Criteria:
- Previous chemotherapy for this malignancy
- Previous radiotherapy to head and neck region
- Other malignancy within last 5 years except for non-melanoma skin cancer
- Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
- Peripheral neuropathy > Grade 2
- Hypercalcemia
- Patient is pregnant or lactating
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| NCT ID: |
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NCT00982436 |
| Primary Contact: |
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Principal Investigator
Steven M Grunberg, MD
University of Vermont/Feltcher Allen Health Care
Steven M Grunberg, MD
Phone: 802-847-8400
Email: Steven.Grunberg@vtmednet.org
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| Backup Contact: |
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Email: Madhuri.Vithala@vtmednet.org
Madhuri V Vithala, MD
Phone: 802-847-8400
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| Location Contact: |
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Colchester, Vermont 05446
United States
Christian Thomas, MD
Phone: 802-655-3400
Email: Christian.Thomas@vtmednet.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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