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
Overview
- Phase
- Phase 1
- Intervention
- Docetaxel/cisplatin
- Conditions
- Head and Neck Neoplasms
- Sponsor
- University of Vermont
- Enrollment
- 37
- Locations
- 3
- Primary Endpoint
- Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
Steven Grunberg
Professor of Medicine
University of Vermont
Eligibility 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
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
Arms & Interventions
Neoadjuvant/Concomitant Chemoradiation
Three cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin
Intervention: Docetaxel/cisplatin
Neoadjuvant/Concomitant Chemoradiation
Three cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin
Intervention: Radiotherapy
Neoadjuvant/Concomitant Chemoradiation
Three cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin
Intervention: Carboplatin
Outcomes
Primary Outcomes
Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Time Frame: 6 months after initiation of therapy
Secondary Outcomes
- Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer(3 months after initiation of therapy)
- Response rate to chemoradiotherapy in locally advanced squamous head and neck cancer(6 months after initiation of therapy)
- Toxicity of neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer(Every 3 weeks for 6 months (during therapy))
- Progression free survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer(Every 6 months)
- Overall survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer(Every 6 months)