S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer

NCT00084435 | Withdrawn Phase 2

• 3 other identifiers: CDR0000365311S0217U10CA032102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Disease progression

• Disease-free survival

• Symptomatic deterioration

• Toxicity

Study Arms (1)

chemoRT after surgery

EXPERIMENTAL

chemoRT with cisplatin and docetaxel after surgery

Drug: cisplatin; Drug: docetaxel; Radiation: radiation therapy

Interventions

cisplatin DRUG

75 mg/m2 IV, Day 1, q 21 days for 3 cycles

Also known as: platinol

chemoRT after surgery

docetaxel DRUG

15 mg/m2 IV, Day 1, 1 7 days for 6 doses

Also known as: taxotere

chemoRT after surgery

radiation therapy RADIATION

200 cGy/day, Days 1-5, q week for 6 weeks

Also known as: RT

chemoRT after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (29)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Riverside Cancer Services

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Mercy Medical Center

Springfield, Ohio, 45504, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

Westerville, Ohio, 43081, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Salivary Gland Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Docetaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Study Officials

• Prakash C. Neupane, MD

  St. Mary's Cancer Specialists at St. Mary's Health Center

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: July 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

US (29)