Recruiting
Phase 1
Phase 2

CDDP/TXT & Chemoradiation

Sponsor:

University of Vermont

Code:

NCT00982436

Conditions

Head and Neck Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Docetaxel/cisplatin

Radiotherapy

Carboplatin

Study Details

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.

Conditions

Head and Neck Neoplasms

Study ID

NCT00982436

Start date

Sep, 2009

Status verified date

Mar, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

37 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neoadjuvant/Concomitant Chemoradiation

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

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

Radiotherapy

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

Carboplatin

Carboplatin AUC 1.5 intravenous weekly during radiotherapy

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Steven M Grunberg, MD

802-847-8400Steven.Grunberg@vtmednet.org

Madhuri V Vithala, MD

802-847-8400Madhuri.Vithala@vtmednet.org

Locations

Mountainview Medical Center

Recruiting

Berlin, Vermont, United States, 05602

Contacts

John Valentine, MD

802-225-5400john.valentine@cvmc.org

Principal Investigator:

John Valentine, MD

Fletcher Allen Health Care

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Steven Grunberg, MD

802-847-8400Steven.Grunberg@vtmednet.org

Madhuri V Vithala, MD

802-847-8400Madhuri.Vithala@vtmednet.org

Principal Investigator:

Steven M Grunberg, MD

Vermont Center for Cancer Medicine

Recruiting

Colchester, Vermont, United States, 05446

Contacts

Christian Thomas, MD

802-655-3400Christian.Thomas@vtmednet.org

More Information

Sponsor

University of Vermont

Last update posted

Mar 22, 2012

Last verified

Mar, 2012

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2012-03-22.