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

NCT ID: NCT00982436

Last Updated: 2012-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant/Concomitant Chemoradiation

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

Group Type: EXPERIMENTAL

Docetaxel/cisplatin

Intervention Type: DRUG

Docetaxel 75 mg/m2 intravenous every 3 weeks for 3 cycles Cisplatin 75 mg/m2 intravenous every 3 weeks for 3 cycles

Radiotherapy

Intervention Type: RADIATION

70 Gy in 35 fractions to gross tumor and lymph node metastases

Carboplatin

Intervention Type: DRUG

Carboplatin AUC 1.5 intravenous weekly during radiotherapy

Interventions

Docetaxel/cisplatin

Docetaxel 75 mg/m2 intravenous every 3 weeks for 3 cycles Cisplatin 75 mg/m2 intravenous every 3 weeks for 3 cycles

Intervention Type: DRUG

Radiotherapy

70 Gy in 35 fractions to gross tumor and lymph node metastases

Intervention Type: RADIATION

Carboplatin

Carboplatin AUC 1.5 intravenous weekly during radiotherapy

Intervention Type: DRUG

Other Intervention Names

Taxotere; Platinol; Radiation therapy; Paraplatin

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Steven Grunberg

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven M Grunberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont/Feltcher Allen Health Care

Locations

Mountainview Medical Center

Berlin Corners, Vermont, United States

Site Status: RECRUITING

Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status: RECRUITING

Vermont Center for Cancer Medicine

Colchester, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven M Grunberg, MD

Role: CONTACT

Steven.Grunberg@vtmednet.org

802-847-8400

Madhuri V Vithala, MD

Role: CONTACT

Madhuri.Vithala@vtmednet.org

802-847-8400

Facility Contacts

John Valentine, MD

Role: primary

john.valentine@cvmc.org

802-225-5400

Steven Grunberg, MD

Role: primary

Steven.Grunberg@vtmednet.org

802-847-8400

Madhuri V Vithala, MD

Role: backup

Madhuri.Vithala@vtmednet.org

802-847-8400

Christian Thomas, MD

Role: primary

Christian.Thomas@vtmednet.org

802-655-3400

Other Identifiers

VCC 0905

Identifier Type: -

Identifier Source: org_study_id