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

NCT00982436 | Unknown Phase 1 DMC

• 1 other identifier: VCC 0905
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

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

Keywords

Combined Modality Therapy; Neoadjuvant Therapy; Head and neck neoplasms

Outcome Measures

Primary Outcomes (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 Outcomes (5)

• Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer

  3 months after initiation of therapy

• Response rate to chemoradiotherapy in locally advanced squamous head and neck cancer

  6 months after initiation of therapy

• 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)

• Progression free survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer

  Every 6 months

• Overall survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer

  Every 6 months

Study Arms (1)

Neoadjuvant/Concomitant Chemoradiation

EXPERIMENTAL

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

Drug: Docetaxel/cisplatin; Radiation: Radiotherapy; Drug: Carboplatin

Interventions

Docetaxel/cisplatin DRUG

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

Also known as: Taxotere, Platinol

Neoadjuvant/Concomitant Chemoradiation

Radiotherapy RADIATION

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

Also known as: Radiation therapy

Neoadjuvant/Concomitant Chemoradiation

Carboplatin DRUG

Carboplatin AUC 1.5 intravenous weekly during radiotherapy

Also known as: Paraplatin

Neoadjuvant/Concomitant Chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (3)

Mountainview Medical Center

Berlin Corners, Vermont, 05602, United States

RECRUITING

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

RECRUITING

Vermont Center for Cancer Medicine

Colchester, Vermont, 05446, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Cisplatin; Radiotherapy; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics; Coordination Complexes

Study Officials

• Steven M Grunberg, MD

  University of Vermont/Feltcher Allen Health Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven M Grunberg, MD

CONTACT

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

Madhuri V Vithala, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

US (3)