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

Sponsor
University of Vermont (Other)
Overall Status
Unknown status
CT.gov ID
NCT00982436
Collaborator
(none)
37
Enrollment
3
Locations
1
Arm
39
Duration (Months)
12.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2009
Anticipated Primary Completion Date :
Sep 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer [6 months after initiation of therapy]

    Secondary Outcome Measures

    1. Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer [3 months after initiation of therapy]

    2. Response rate to chemoradiotherapy in locally advanced squamous head and neck cancer [6 months after initiation of therapy]

    3. 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)]

    4. Progression free survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer [Every 6 months]

    5. Overall survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer [Every 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mountainview Medical Center Berlin Vermont United States 05602
    2 Fletcher Allen Health Care Burlington Vermont United States 05401
    3 Vermont Center for Cancer Medicine Colchester Vermont United States 05446

    Sponsors and Collaborators

    • University of Vermont

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Steven Grunberg, Professor of Medicine, University of Vermont
    ClinicalTrials.gov Identifier:
    NCT00982436
    Other Study ID Numbers:
    • VCC 0905
    First Posted:
    Sep 23, 2009
    Last Update Posted:
    Mar 22, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Steven Grunberg, Professor of Medicine, University of Vermont
    Combined Modality Therapy
    Neoadjuvant Therapy
    Head and neck neoplasms
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Carboplatin
    Docetaxel

    Study Results

    No Results Posted as of Mar 22, 2012