Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: docetaxel Procedure: conventional surgery Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT) |
| Study Start Date: | March 2000 |
OBJECTIVES:
- Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy.
- Determine the toxicity of this treatment regimen in this patient population.
- Determine the efficacy of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks.
Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy.
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD.
Patients are followed monthly for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) or its variants (e.g., lymphoepithelioma or undifferentiated epidermoid carcinoma)
- Stage III or IV (M0) disease
Must have had prior platinum/fluorouracil based initial induction chemotherapy (may have included a taxane)
- Previously untreated disease prior to induction regimen
- Received 1-3 courses of chemotherapy and less than 7 weeks from the beginning of the last course of induction therapy
- Evaluable disease during induction therapy required
- No prior head and neck carcinoma except if treated with surgery as sole modality at least 2 years prior to study
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Greater than 3 months
Hematopoietic:
- WBC at least 3,000/mm^3 OR
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL (transfusion allowed)
Hepatic:
- SGOT less than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2.5 times ULN
- Bilirubin normal
- SGOT no greater than 2 times ULN
Renal:
- Not specified
Cardiovascular:
- No acute cardiac dysrhythmias or unstable cardiac condition (e.g., angina)
Other:
- No other concurrent malignancy within the past 3 years except curatively treated limited basal or squamous cell skin cancer or carcinoma in situ of the cervix
- Adequate and nutritionally balanced enteral intake (at least 1,800 kcal/day)
- No persistent diarrhea
- No peripheral neuropathy of any etiology greater than grade 2
- No other serious illness or medical condition
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 5 years since any other form of prior chemotherapy
Endocrine therapy:
- Prior hormonal therapy allowed
Radiotherapy:
- No prior radiotherapy for SCCHN
Surgery:
- See Disease Characteristics
- Percutaneous endoscopic gastrostomy required prior to radiotherapy
Other:
- No IV alimentation as primary source of calories
- Completely recovered from prior diagnostic or therapeutic procedures
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | Roy B. Tishler, MD, PhD | Dana-Farber Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006107 History of Changes |
| Other Study ID Numbers: | CDR0000068118, DFCI-99274, NCI-G00-1833 |
| Study First Received: | August 3, 2000 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx |
stage IV squamous cell carcinoma of the larynx recurrent 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 recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer stage III salivary gland cancer stage IV salivary gland cancer salivary gland squamous cell carcinoma recurrent lymphoepithelioma of the nasopharynx recurrent lymphoepithelioma of the oropharynx stage III lymphoepithelioma of the nasopharynx stage III lymphoepithelioma of the oropharynx stage IV lymphoepithelioma of the nasopharynx stage IV lymphoepithelioma of the oropharynx |
Additional relevant MeSH terms:
|
Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms by Site Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013