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Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer
Conditions
Head and Neck Neoplasms
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Combined Modality Therapy, Neoadjuvant Therapy, Head and neck neoplasms
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel/cisplatin
Type: Drug
Name: Radiotherapy
Type: Radiation
Name: Carboplatin
Type: Drug
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Locations
Mountainview Medical Center
Berlin, Vermont, United States
Fletcher Allen Health Care
Status: Recruiting
Contact: John Valentine, MD - 802-225-5400 - john.valentine@cvmc.org
Burlington, Vermont, United States
Vermont Center for Cancer Medicine
Status: Recruiting
Contact: Steven Grunberg, MD - 802-847-8400 - Steven.Grunberg@vtmednet.org
Colchester, Vermont, United States
Status: Recruiting
Contact: Christian Thomas, MD - 802-655-3400 - Christian.Thomas@vtmednet.org
Start Date
September 2009
Completion Date
December 2012
Sponsors
University of Vermont
Source
University of Vermont
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page