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

Primary Purpose

Head and Neck Neoplasms

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Docetaxel/cisplatin

Radiotherapy

Carboplatin

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Combined Modality Therapy, Neoadjuvant Therapy, Head and neck neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mountainview Medical CenterRecruiting
Fletcher Allen Health CareRecruiting
Vermont Center for Cancer MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant/Concomitant Chemoradiation

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer

Secondary Outcome Measures

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

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

Toxicity of neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer

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

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

Full Information

NCT ID

NCT00982436

First Posted

September 22, 2009

Last Updated

March 21, 2012

Sponsor

University of Vermont

1. Study Identification

Unique Protocol Identification Number

NCT00982436

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Vermont

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Neoplasms

Keywords

Combined Modality Therapy, Neoadjuvant Therapy, Head and neck neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant/Concomitant Chemoradiation

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel/cisplatin

Other Intervention Name(s)

Taxotere, Platinol

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

Radiation therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin

Intervention Description

Carboplatin AUC 1.5 intravenous weekly during radiotherapy

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

3 months after initiation of therapy

Title

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

Time Frame

6 months after initiation of therapy

Title

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)

Title

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

Title

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

Time Frame

Every 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Steven M Grunberg, MD

Phone

802-847-8400

Steven.Grunberg@vtmednet.org

First Name & Middle Initial & Last Name or Official Title & Degree

Madhuri V Vithala, MD

Phone

802-847-8400

Madhuri.Vithala@vtmednet.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven M Grunberg, MD

Organizational Affiliation

University of Vermont/Feltcher Allen Health Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mountainview Medical Center

City

Berlin

State/Province

Vermont

ZIP/Postal Code

05602

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John Valentine, MD

Phone

802-225-5400

john.valentine@cvmc.org

First Name & Middle Initial & Last Name & Degree

John Valentine, MD

First Name & Middle Initial & Last Name & Degree

David Ospina, MD

First Name & Middle Initial & Last Name & Degree

Daniel Fram, MD

Facility Name

Fletcher Allen Health Care

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steven Grunberg, MD

Phone

802-847-8400

Steven.Grunberg@vtmednet.org

First Name & Middle Initial & Last Name & Degree

Madhuri V Vithala, MD

Phone

802-847-8400

Madhuri.Vithala@vtmednet.org

First Name & Middle Initial & Last Name & Degree

Steven M Grunberg, MD

First Name & Middle Initial & Last Name & Degree

Madhuri V Vithala, MD

First Name & Middle Initial & Last Name & Degree

Havaleh Gagne, MD

First Name & Middle Initial & Last Name & Degree

William Brundage, MD

Facility Name

Vermont Center for Cancer Medicine

City

Colchester

State/Province

Vermont

ZIP/Postal Code

05446

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian Thomas, MD

Phone

802-655-3400

Christian.Thomas@vtmednet.org

First Name & Middle Initial & Last Name & Degree

Paul Unger, MD

First Name & Middle Initial & Last Name & Degree

Dennis Sanders, MD

First Name & Middle Initial & Last Name & Degree

Johannes Nunnink, MD

First Name & Middle Initial & Last Name & Degree

Christian Thomas, MD

12. IPD Sharing Statement

Learn more about this trial

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

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