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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00982436
Other study ID # VCC 0905
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received September 22, 2009
Last updated March 21, 2012
Start date September 2009
Est. completion date December 2012

Study information

Verified date March 2012
Source University of Vermont
Contact Steven M Grunberg, MD
Phone 802-847-8400
Email Steven.Grunberg@vtmednet.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 37
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
Radiation:
Radiotherapy
70 Gy in 35 fractions to gross tumor and lymph node metastases
Drug:
Carboplatin
Carboplatin AUC 1.5 intravenous weekly during radiotherapy

Locations

Country Name City State
United States Mountainview Medical Center Berlin Vermont
United States Fletcher Allen Health Care Burlington Vermont
United States Vermont Center for Cancer Medicine Colchester Vermont

Sponsors (1)

Lead Sponsor Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer 3 months after initiation of therapy No
Secondary Response rate to chemoradiotherapy in locally advanced squamous head and neck cancer 6 months after initiation of therapy No
Secondary 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) Yes
Secondary Progression free survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer Every 6 months No
Secondary Overall survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer Every 6 months No
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