Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer

University of Vermont

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Head and Neck Neoplasms

Treatments: Radiation: Radiotherapy; Drug: Carboplatin; Drug: Docetaxel/cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00982436

VCC 0905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Neoadjuvant/Concomitant Chemoradiation

Experimental group

Description:

Three cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin

Treatment:

Drug: Docetaxel/cisplatin

Drug: Carboplatin

Radiation: Radiotherapy