Chemotherapy Plus Radiation Therapy in Treating Patients With Squamous Cell Cancer of the Head and Neck

NCT00003200 | Completed Phase 1 DMC

• 3 other identifiers: 95-041P30CA006516NCI-G98-1382
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this research study is to develop a new chemo radiotherapy regimen for the treatment of cancer of the head and neck for patients who have received induction chemotherapy; and to determine the highest dose of Taxotere which can be safely given together with radiotherapy.

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 oropharynx; stage III lymphoepithelioma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV lymphoepithelioma of the oropharynx; stage III squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; 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 paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity

Outcome Measures

Primary Outcomes (2)

• MTD of weekly Taxotere

  6 Weeks

• Number of Participants of with Severe Adverse Events

  6 Weeks

Study Arms (1)

Taxotere

EXPERIMENTAL

After the screening procedures confirm participation in the research study: * Taxotere-Administered weekly for 1 hour (6 doses) * Radiation Therapy (XRT) -5 days a week for 6 weeks * Exam under anesthesia * Neck Dissection (if indicated)

Drug: Taxotere; Radiation: Radiation therapy

Interventions

Taxotere DRUG

Also known as: Docetaxel

Taxotere

Radiation therapy RADIATION

Taxotere

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Pathology: Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc) * Stage: Patients can be entered on this protocol after initial induction therapy, if prior to the induction regimen, they were previously untreated Stage III or IV (MO) SCCHN. This excludes patients with exophytic T3N0 tumors or T1N1 lesions at the onset of induction therapy. Evaluable disease during induction therapy is required. --Required Prior therapy: Patients entered on this protocol must have received therapy with one of the following induction regimens, except as modified for toxicity: * PF: Cisplatin ≥ 80 mg/M2?course and FUra ≥ 1000 mg/M2/day for ≥ 4 days every ≤ 4 week * CF: Carboplatinum ≥ 300 mg/M2/course and FUra ≥1000mg/M2/day for ≥4 days for ≤ 4 week * PFL5: Cisplatin ≥ 25 mg/M2/day over 5 days, FUra ≥ 800mg/M2/day days 2-5 (4 days) and Leucovorin ≥ 500 mg/M2/day over 5 days, every 4 weeks. * TPF: Taxotere, Cisplatin ≥ 100 mg/M2/day over 5 days, FUra ≥ 700 mg/M2?day days 2-5 (4 days) * Patients treated as above are eligible provided that they receive no more than three cycles or, if not responding after 2 cycles; or 1 cycle with progressive disease p. 35 of archive doc * Other Malignancies: * Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality 2 years prior to study entry. * Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. * Patient with any non-SCCHN malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. * Other Prior Therapy: Patients who were previously treated with radiotherapy for SCCHN are not eligible. Patients treated with any form of prior chemotherapy , other than induction therapy described in section 3.21 within the last 5 years are not eligible. Hormonally treated patients are eligible. * Performance: Patients must meet the following performance criteria: * Performance status: 2 ECOG. Complete recovery from previous diagnostic or therapeutic procedures is required. * Nutritional status: Adequate and nutritionally balances enteral intake (1,800 kcal/day). Patients requiring intravenous alimentation as primary source of calories are excluded from this study. Patients who experiences a weight loss of more than 20% of their body weight in the three months preceding presentation are ineligible. Patients with persistent diarrhea are ineligible. * Life Expectancy: Longer than 3 Months * Women of child bearing potential must not be pregnant by history or lactating at the time of entry on this protocol and men and women of child bearing potential must be requested to use an accepted and effective method of birth control during therapy. * Organ Function: Biochemical and hematological parameters (obtained within 2 weeks of study entry) as follows: * Hepatic: SGOT \< 1.5 x ULN and Alkaline Phosphatase \< 2.5x ULN for entry. Total Bilirubin and SGOT must be ≤ 2 x ULN as an isolated value. Alkaline phosphatase must be ≤ 2.5 x ULN as an isolated value. * Hematologic: WBC 4,000/mm3 or a normal absolute neutrophil count (ANC); Platelet count 100,000/mm3, Hemoglobin 10 gm/dl (transfusion to bring the hemoglobin to or above this level is permitted if clinically indicated, however, transfusions should not be used solely in order to eligibility criteria) * Neurologic: Peripheral neuropathy of any etiology must not exceed grade 1. * Cardiovascular/Pulmonary: No acute cardiac dysrhythmias or unstable cardiac condition such as angina * Other: Lack of other serious illness or medical condition * Allergies: Patients with prior allergy to polysorbate 80 (see appendix) are ineligible * Informed Consent: Patients must give written informed consent * Follow-up: All patients must be available for monthly evaluation and restaging by the head and neck cancer clinic on therapy

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Harvard Community Health Plan

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

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

Interventions

Docetaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Study Officials

• Marshall R. Posner, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Haddad, Robert MD

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 13, 2004
• Study Start: October 1, 1995
• Primary Completion: October 1, 2006
• Study Completion: June 1, 2008
• Last Updated: January 19, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)