Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments cisplatin, paclitaxel, intensity-modulated radiation therapy (imrt) external beam radiation, triple endoscopy and biopsy
Phase phase 2
Sponsor Ohio State University Comprehensive Cancer Center
Start date December 2007
End date December 2013
Trial size 50 participants
Trial identifier NCT00566540, NCI-2011-02687, OSU-06026

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving cisplatin and paclitaxel together with radiation therapy and surgery works in treating patients with advanced cancer of the oral cavity, oropharynx, or hypopharynx that can be removed by surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
PREOPERATIVE:Patients receive cisplatin IV over 2 hours three times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10.
cisplatin Platinol-®AQ
Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.
paclitaxel Taxol®
Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10
intensity-modulated radiation therapy (imrt) external beam radiation radiation therapy
Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nodes 20Gy over 10 daily (M-F) treatments (2 Gy Fractions with 6 millivolts photons)week 1 and 2.
triple endoscopy and biopsy
Resection of the primary tumor: Patients must have surgery performed according to the following surgical guidelines. The extent of the surgical resection will be dictated by the extent of the tumor at the time of initial evaluation. The primary lesion must be widely excised using accepted criteria for adequate excision depending on the region involved. All patients will undergo percutaneous endoscopic gastrostomy tube placement at the time of endoscopy and biopsies.

Primary Outcomes

Measure
Feasibility of treatment
time frame: Up to one year

Secondary Outcomes

Measure
Disease-free interval and failure sites
time frame: Up to one year
Correlation of molecular markers with treatment outcome
time frame: Up to week 14
Correlation of quality of life with treatment outcome
time frame: Up to one year
Frequency and severity of toxicities
time frame: Up to one year
Treatment completion
time frame: up to one year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients must have a Karnofsky Performance Index ≥60% - Patients must be over the age of 18. - Patients must have a life expectancy of at least 6 months. - Women of childbearing age must have a negative serum pregnancy test and agree to use an effective method of contraceptive. - Patients with a cardiac history should be cleared with a medical internist. In general, patients with a history of prior bradyarrythmias, atrioventricular (AV) conduction defects or marginal cardiac function will be eligible. - Patients must have resectable stage III, stage IVA, stage IVB (without distant metastases) squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx. Hypopharyngeal carcinomas may also be stage II. - Patients must not have had prior chemotherapy or radiotherapy (to the primary site or nodes). - Patients may not be planning to receive while on study concomitant immunotherapy or hormonal therapy, except oral contraceptives or hormone replacement therapy. - Patients must have adequate hepatic function documented by a normal serum bilirubin 0- 1.5mg/L and serum transaminases < 4 x upper limit. - Patients must have adequate renal function documented by a serum creatinine not above upper institutional normal limits and/or 24 hour OR calculated creatinine clearance >60 ml/min. using the following formula: (140-age) x Wt (kg) x .85 (if Estimated Creatinine Clearance = 72 x Creatinine (mg/dl) female) - Patients must have adequate bone marrow function documented by platelet count ≥ 100,000 and absolute neutrophil count ≥ 2,000. - Patients will have surgery according to Section 5.3. Operative and pathology reports must be sufficiently detailed to confirm that surgery was done according to the guidelines. - Patients must be examined by a multi-modality team (consisting of a head and neck surgeon, medical oncologist, and radiation oncologist) prior to entry on study. - All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: - Distant metastases. - Prior malignancy, except for 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 five years. - Any condition that would be considered a contraindication for fluid challenge. - Pregnant or lactating women may not participate. - History of demyelinating neurological disorder, such as multiple sclerosis - History of pancytopenia or aplastic anemia.

Additional Information

Official title Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, and Hypopharynx: Incorporation of Intensity Modulated Radiotherapy and Submandibular Gland Transfer to Minimize Treatment Morbidity; Correlative Imaging/Molecular Markers.
Principal investigator David E. Schuller, MD
Description OBJECTIVES: Primary - Determine the feasibility of a new intensification regimen comprising cisplatin and paclitaxel in combination with radiotherapy and surgery in patients with resectable advanced squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx. Secondary - Assess the disease-free interval and failure sites in patients treated with this regimen. - Correlate molecular markers with treatment outcome in these patients. - Correlate quality of life with treatment outcome in these patients. - Determine the frequency and severity of toxicities of this regimen in these patients. - Evaluate treatment completion in these patients. OUTLINE: - Preoperative therapy (weeks 1 and 2): Patients receive cisplatin IV over 2 hours on days 1-3. Patients also undergo intensity-modulated external beam radiotherapy once daily on days 1-5 and 8-12. - Surgery (week 3): Patients undergo surgical resection of the primary tumor (with or without neck dissection) and intraoperative boost radiotherapy. - Postoperative therapy (weeks 7-10): Patients receive cisplatin IV over 2 hours on days 1-3 and 22-24 and paclitaxel IV over 3 hours on days 1, 8, 15, and 22. Patients also undergo intensity-modulated external beam radiotherapy on days 1-5, 8-12, 15-19, and 22-26. Patients undergo blood and tissue sample collection at baseline, in weeks 3, 7-10, and 14, and then periodically thereafter for biomarker correlative studies. Quality of life is assessed at baseline, at 3, 6, and 12 months after completion of treatment, and then annually thereafter. After completion of study treatment, patients are followed every 2 months for 1 year and then periodically thereafter.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.