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

March 21, 2012 updated by: Steven Grunberg, University of Vermont

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Recruiting
        • Mountainview Medical Center
        • Contact:
        • Principal Investigator:
          • John Valentine, MD
        • Sub-Investigator:
          • David Ospina, MD
        • Sub-Investigator:
          • Daniel Fram, MD
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • Fletcher Allen Health Care
        • Principal Investigator:
          • Steven M Grunberg, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Madhuri V Vithala, MD
        • Sub-Investigator:
          • Havaleh Gagne, MD
        • Sub-Investigator:
          • William Brundage, MD
      • Colchester, Vermont, United States, 05446
        • Recruiting
        • Vermont Center for Cancer Medicine
        • Sub-Investigator:
          • Christian Thomas, MD
        • Sub-Investigator:
          • Paul Unger, MD
        • Sub-Investigator:
          • Dennis Sanders, MD
        • Sub-Investigator:
          • Johannes Nunnink, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant/Concomitant Chemoradiation
Three cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin
Drug: Docetaxel/cisplatin
Docetaxel 75 mg/m2 intravenous every 3 weeks for 3 cycles Cisplatin 75 mg/m2 intravenous every 3 weeks for 3 cycles
Other Names:
  • Taxotere
  • Platinol
Radiation: Radiotherapy
70 Gy in 35 fractions to gross tumor and lymph node metastases
Other Names:
  • Radiation therapy
Drug: Carboplatin
Carboplatin AUC 1.5 intravenous weekly during radiotherapy
Other Names:
  • Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months after initiation of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer
Time Frame: 3 months after initiation of therapy
3 months after initiation of therapy
Response rate to chemoradiotherapy in locally advanced squamous head and neck cancer
Time Frame: 6 months after initiation of therapy
6 months after initiation of therapy
Toxicity of neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Time Frame: Every 3 weeks for 6 months (during therapy)
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
Time Frame: Every 6 months
Every 6 months
Overall survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Time Frame: Every 6 months
Every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Principal Investigator: Steven M Grunberg, MD, University of Vermont/Feltcher Allen Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 21, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCC 0905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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