S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
This study has been withdrawn prior to enrollment.
(Poor accrual and suspension of head and neck committee)
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00084435
First received: June 10, 2004
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: cisplatin Drug: docetaxel Radiation: radiation therapy |
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: | Adjuvant Chemo-RT With Cisplatin (NSC-119875) and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Disease progression [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Symptomatic deterioration [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | July 2005 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: chemoRT after surgery
chemoRT with cisplatin and docetaxel after surgery
|
Drug: cisplatin
75 mg/m2 IV, Day 1, q 21 days for 3 cycles
Other Name: platinol
Drug: docetaxel
15 mg/m2 IV, Day 1, 1 7 days for 6 doses
Other Name: taxotere
Radiation: radiation therapy
200 cGy/day, Days 1-5, q week for 6 weeks
Other Name: RT
|
Detailed Description:
OBJECTIVES:
- Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin.
- Determine the toxicity of this regimen in these patients.
- Categorize the site(s) of disease relapse in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of squamous cell carcinoma of the head and neck
Selected stage III or IV (no distant metastasis) disease
The following TNM stages are excluded:
- T3, N0, M0
- T4a, N0, M0
- T4b, N3, M0
- Any T, any N, M1
Complete total resection within the past 56 days AND has one or more of the following risk factors:
- Multiple pathologically confirmed lymph node metastases
- One or more lymph nodes with extracapsular extension of tumor
- Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection
- No primary nasopharyngeal carcinoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- SGOT or SGPT ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance ≥ 60 mL/min
Other
- No pre-existing peripheral neuropathy
- No known history of severe hypersensitiviy reaction to products containing Polysorbate 80
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for the malignancy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for the malignancy
Surgery
- See Disease Characteristics
Other
- No concurrent amifostine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084435
Locations
| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| United States, Illinois | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Regional Cancer Center at Memorial Medical Center | |
| Springfield, Illinois, United States, 62781-0001 | |
| United States, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Louisiana | |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Saint Louis University Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, North Carolina | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| United States, Ohio | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| Grant Riverside Cancer Services | |
| Columbus, Ohio, United States, 43215 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Community Oncology Group at Cleveland Clinic Cancer Center | |
| Independence, Ohio, United States, 44131 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Mercy Medical Center | |
| Springfield, Ohio, United States, 45504 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| Cleveland Clinic - Wooster | |
| Wooster, Ohio, United States, 44691 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| United States, South Carolina | |
| AnMed Health Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
Sponsors and Collaborators
Southwest Oncology Group
Investigators
| Principal Investigator: | Prakash C. Neupane, MD | St. Mary's Cancer Specialists at St. Mary's Health Center |
| Study Chair: | Harold E. Kim, MD | Barbara Ann Karmanos Cancer Institute |
| Study Chair: | Stephen K. Williamson, MD | University of Kansas |
| Study Chair: | George H. Yoo, MD | Barbara Ann Karmanos Cancer Institute |
More Information
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00084435 History of Changes |
| Other Study ID Numbers: | CDR0000365311, S0217, U10CA032102 |
| Study First Received: | June 10, 2004 |
| Last Updated: | June 13, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity stage III salivary gland cancer stage IV salivary gland cancer stage III squamous cell carcinoma of the hypopharynx |
stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx salivary gland squamous cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
Docetaxel Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013