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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer

Outcome Time Frame:

6 months after initiation of therapy

Safety Issue:

No

Principal Investigator

Steven M Grunberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Vermont/Feltcher Allen Health Care

Authority:

United States: Institutional Review Board

Study ID:

VCC 0905

NCT ID:

NCT00982436

Start Date:

September 2009

Completion Date:

December 2012

Related Keywords:

  • Head and Neck Neoplasms
  • Combined Modality Therapy
  • Neoadjuvant Therapy
  • Head and neck neoplasms
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location

Fletcher Allen Health CareBurlington, Vermont  05401
Mountainview Medical CenterBerlin, Vermont  05602
Vermont Center for Cancer MedicineColchester, Vermont  05446