Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as gemcitabine and cisplatin may make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy before surgery or radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy followed by surgery, chemotherapy, and radiation therapy works in treating patients with locally advanced head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: cisplatin Drug: docetaxel Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Genetic: gene expression analysis Genetic: protein expression analysis Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: biopsy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multimodality Management of Head and Neck Cancer: A Phase II Trial of Induction Chemotherapy, Organ Preservation Surgery, and Concurrent Chemoradiotherapy |
- Complete and overall response rate [ Designated as safety issue: No ]
- Feasibility [ Designated as safety issue: No ]
- Prospective impact of neoadjuvant chemotherapy, concurrent chemoradiotherapy, and organ preservation surgery on overall survival, time to progression, and pattern of disease recurrence [ Designated as safety issue: No ]
- Biochemical correlates [ Designated as safety issue: No ]
- Treatment-associated morbidity [ Designated as safety issue: No ]
- Comparison of diagnostic salivary cytology with histopathology at initial diagnosis and at follow-up [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2000 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To assess the complete and overall response rate of neoadjuvant docetaxel, cisplatin, fluorouracil, and leucovorin calcium in previously untreated patients with local regionally advanced head and neck cancer.
- To evaluate the feasibility of a multimodality treatment approach with the goal of reducing long-term sequelae.
- To evaluate prospectively, the impact of neoadjuvant chemotherapy, concurrent chemoradiotherapy, and organ preservation surgery on overall survival, time to progression, and pattern of disease recurrence in these patients.
- To evaluate prospectively, biochemical correlates of response and prognosis, including markers such as thymidylate synthetase, ribonucleotide reductase, and ERCC1 (measured by quantitative PCR), p53 (evaluated by IHC), and HPV status and apoptosis (TUNEL assay).
Secondary
- To evaluate treatment-associated morbidity with the use of a quality of life assessment tool.
- To compare the results of diagnostic salivary cytology with those of histopathology at initial diagnosis as well as follow-up in head and neck cancer patients.
- To evaluate the tolerability of combined chemoradiotherapy using gemcitabine and cisplatin after definitive surgery for squamous cell carcinoma of the head and neck.
OUTLINE: Patients receive neoadjuvant induction chemotherapy comprising docetaxel IV over 1 hour on day 1 and cisplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on days 1-4. Induction chemotherapy repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with partial response at the primary site may undergo radical or functional resection of the primary tumor within 3 weeks of completion of neoadjuvant therapy.
Beginning within 4 weeks of completion of neoadjuvant therapy, patients with persistent disease or complete response after chemotherapy at the primary or neck then undergo radiotherapy 5 days a week for 7 weeks and receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes on day 1 of each week of radiotherapy in the absence of disease progression or unacceptable toxicity.
Patients complete the FACT-H&N quality of life questionnaire at baseline and at completion of neoadjuvant therapy.
Tissue biopsies are collected at baseline, periodically during therapy, at surgery, and after radiotherapy. Tissue is examined for gene and protein expression.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck, including any of the following subtypes:
- Oral cavity
- Oropharynx
- Hypopharynx
- Larynx
Stage III or IV disease
- Stage II carcinoma of the larynx, hypopharynx, or base of tongue allowed
- Measurable disease
- Resectable disease, defined as tumors that are potentially curable by surgery and radiotherapy
PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 60%
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min
- Bilirubin ≤ 1.5 mg/dL
Transaminases and alkaline phosphatase meeting 1 of the following criteria:
- ALT or AST ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal
- Alkaline phosphatase ≤ 4 times ULN AND ALT and AST normal
- ALT or AST < 1.5 times ULN AND alkaline phosphatase < 2.5 times ULN
- Free of serious infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior malignancy allowed for purposes of determining disease-free or overall survival except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years
- No unstable angina, history of congestive heart failure, or acute myocardial infarction within the past 6 months
- No current symptomatic, neurosensory or neuromotor toxicity ≥ grade 2
- No other significant medical or psychiatric condition incompatible with the protocol
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for head and neck cancer
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00544414 History of Changes |
| Other Study ID Numbers: | 98147, P30CA033572, CHNMC-98147, CDR0000566884 |
| Study First Received: | October 13, 2007 |
| Last Updated: | October 17, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by City of Hope Medical Center:
|
stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the oropharynx |
stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the oropharynx |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms Gemcitabine Docetaxel Cisplatin Fluorouracil Leucovorin Levoleucovorin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on October 17, 2012
