Trial Title:
Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer
NCT ID:
NCT00982436
Condition:
Head and Neck Neoplasms
Conditions: Official terms:
Head and Neck Neoplasms
Carboplatin
Docetaxel
Conditions: Keywords:
Combined Modality Therapy
Neoadjuvant Therapy
Head and neck neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel/cisplatin
Description:
Docetaxel 75 mg/m2 intravenous every 3 weeks for 3 cycles Cisplatin 75 mg/m2 intravenous
every 3 weeks for 3 cycles
Arm group label:
Neoadjuvant/Concomitant Chemoradiation
Other name:
Taxotere
Other name:
Platinol
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
70 Gy in 35 fractions to gross tumor and lymph node metastases
Arm group label:
Neoadjuvant/Concomitant Chemoradiation
Other name:
Radiation therapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin AUC 1.5 intravenous weekly during radiotherapy
Arm group label:
Neoadjuvant/Concomitant Chemoradiation
Other name:
Paraplatin
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mountainview Medical Center
Address:
City:
Berlin
Zip:
05602
Country:
United States
Status:
Recruiting
Contact:
Last name:
John Valentine, MD
Phone:
802-225-5400
Email:
john.valentine@cvmc.org
Investigator:
Last name:
John Valentine, MD
Email:
Principal Investigator
Investigator:
Last name:
David Ospina, MD
Email:
Sub-Investigator
Investigator:
Last name:
Daniel Fram, MD
Email:
Sub-Investigator
Facility:
Name:
Fletcher Allen Health Care
Address:
City:
Burlington
Zip:
05401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven Grunberg, MD
Phone:
802-847-8400
Email:
Steven.Grunberg@vtmednet.org
Contact backup:
Last name:
Madhuri V Vithala, MD
Phone:
802-847-8400
Email:
Madhuri.Vithala@vtmednet.org
Investigator:
Last name:
Steven M Grunberg, MD
Email:
Principal Investigator
Investigator:
Last name:
Madhuri V Vithala, MD
Email:
Sub-Investigator
Investigator:
Last name:
Havaleh Gagne, MD
Email:
Sub-Investigator
Investigator:
Last name:
William Brundage, MD
Email:
Sub-Investigator
Facility:
Name:
Vermont Center for Cancer Medicine
Address:
City:
Colchester
Zip:
05446
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christian Thomas, MD
Phone:
802-655-3400
Email:
Christian.Thomas@vtmednet.org
Investigator:
Last name:
Paul Unger, MD
Email:
Sub-Investigator
Investigator:
Last name:
Dennis Sanders, MD
Email:
Sub-Investigator
Investigator:
Last name:
Johannes Nunnink, MD
Email:
Sub-Investigator
Investigator:
Last name:
Christian Thomas, MD
Email:
Sub-Investigator
Start date:
September 2009
Completion date:
December 2012
Lead sponsor:
Agency:
University of Vermont
Agency class:
Other
Source:
University of Vermont
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00982436
