Trial record 5 of 802 for:
Open Studies | "Head and Neck Neoplasms"
Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer
This study is currently recruiting participants.
Verified March 2012 by University of Vermont
Sponsor:
University of Vermont
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
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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:
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
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:
|
Head and Neck Neoplasms 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 May 19, 2013