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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Vermont.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Steven Grunberg, University of Vermont
ClinicalTrials.gov Identifier:
NCT00982436
First received: September 22, 2009
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Head and Neck Neoplasms
Drug: Docetaxel/cisplatin
Radiation: Radiotherapy
Drug: Carboplatin
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer [ Time Frame: 3 months after initiation of therapy ] [ Designated as safety issue: No ]
  • Response rate to chemoradiotherapy in locally advanced squamous head and neck cancer [ Time Frame: 6 months after initiation of therapy ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant/Concomitant Chemoradiation
Three cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin
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
Other Names:
  • Taxotere
  • Platinol
Radiation: Radiotherapy
70 Gy in 35 fractions to gross tumor and lymph node metastases
Other Name: Radiation therapy
Drug: Carboplatin
Carboplatin AUC 1.5 intravenous weekly during radiotherapy
Other Name: Paraplatin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982436

Contacts
Contact: Steven M Grunberg, MD 802-847-8400 Steven.Grunberg@vtmednet.org
Contact: Madhuri V Vithala, MD 802-847-8400 Madhuri.Vithala@vtmednet.org

Locations
United States, Vermont
Mountainview Medical Center Recruiting
Berlin, Vermont, United States, 05602
Contact: John Valentine, MD    802-225-5400    john.valentine@cvmc.org   
Principal Investigator: John Valentine, MD         
Sub-Investigator: David Ospina, MD         
Sub-Investigator: Daniel Fram, MD         
Fletcher Allen Health Care Recruiting
Burlington, Vermont, United States, 05401
Contact: Steven Grunberg, MD    802-847-8400    Steven.Grunberg@vtmednet.org   
Contact: Madhuri V Vithala, MD    802-847-8400    Madhuri.Vithala@vtmednet.org   
Principal Investigator: Steven M Grunberg, MD         
Sub-Investigator: Madhuri V Vithala, MD         
Sub-Investigator: Havaleh Gagne, MD         
Sub-Investigator: William Brundage, MD         
Vermont Center for Cancer Medicine Recruiting
Colchester, Vermont, United States, 05446
Contact: Christian Thomas, MD    802-655-3400    Christian.Thomas@vtmednet.org   
Sub-Investigator: Paul Unger, MD         
Sub-Investigator: Dennis Sanders, MD         
Sub-Investigator: Johannes Nunnink, MD         
Sub-Investigator: Christian Thomas, MD         
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Steven M Grunberg, MD University of Vermont/Feltcher Allen Health Care
  More Information

No publications provided

Responsible Party: Steven Grunberg, Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT00982436     History of Changes
Other Study ID Numbers: VCC 0905
Study First Received: September 22, 2009
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Combined Modality Therapy
Neoadjuvant Therapy
Head and neck neoplasms

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Docetaxel
Cisplatin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014