A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT) and Chemotherapy in Recurrent and Inoperable Squamous Cell Carcinoma (SCC) of the Head and Neck After Radiotherapy Failure
Conditions
Squamous Cell Carcinoma of the Head and Neck
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Low-Dose Fractionated Radiation Therapy/Paclitaxel
Type: Radiation
Overall Status
Recruiting
Summary
The purpose of this study is to determine if low-dose radiation therapy and the chemotherapy drug paclitaxel is effective in treating head and neck cancer that has returned after treatment with standard radiation therapy alone, but cannot be removed by surgery. The overall total dose received of both the chemotherapy and radiation therapy will be less than that typically given as standard of care; however, the Food and Drug Administration (FDA) has not evaluated the safety and effectiveness of this combination therapy. In addition, this study will gather information about the effects of radiation therapy and chemotherapy on subject's overall quality of life.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Subject 18 years of age and older, male or female, of all races and ethnicities.

2. Subject with prior histologically confirmed advanced squamous-cell carcinoma of the head and neck that failed prior traditional chemoradiotherapy with at least a 3-month disease-free interval from the completion of the initial curative treatment.

3. Recurrence must have been confirmed via biopsy.

4. Subject must have an ECOG performance status of 0, 1 or 2.

5. Has undergone CT imaging within 21 days prior to treatment as part of routine care.

6. Measurable disease by CT.

7. Subject deemed likely to survive for at least 6 months.

8. Subject is able and willing to provide written informed consent to participate in the study.

9. If the subject is a female of childbearing age, the subject should have a negative urine pregnancy test and be practicing strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after completion of protocol treatment. Women who have had a hysterectomy are exempt from these requirements. This is routine for any patient undergoing treatment.

10. History of laboratory criteria as specified below (within 21 days prior to enrollment) Hemoglobin ≥ 9 g/dl Platelet count >100,000 per microliter CO2 (carbon dioxide): 22-32 meq/L Creatinine: < 1.5 mg/dL or eGFR>40 ml/min Serum bilirubin <1.6 mg/dl. White blood count > 3,000 per microliter or ANC > 1500 per microliter Serum calcium <10.5 mg/dl.

Exclusion Criteria:

1. The tumor is not clearly shown on diagnostic imaging studies

2. Subject is pregnant.

3. Subject with known allergies/hypersensitivity to paclitaxel.

4. Subjects with poor renal function as demonstrated by serum creatinine (>1.5 mg/dl) and EGFR <40 mL/min, which would preclude the using of image contrast agents.

5. Subject with a planned surgical procedure within the next 30 days.

6. Subject has distant metastasis (with the exception of single stable distant metastasis that does not decrease life expectancy to less than 6 months).

7. Subject is of childbearing potential and will not use adequate contraceptive protection.

8. Subject who is breastfeeding.

9. Subject of childbearing potential who has a positive (+) urine pregnancy test.

10. Subject has received treatment with an experimental drug or entered another clinical trial within the prior 30 days.

11. Subject has received radiotherapy to the head and neck region within the prior 3 months.

12. Subject is not willing or able to complete the visit requirements of this protocol.

13. Peripheral neuropathy of any etiology.

14. Any other condition that the PI feels will be an endangerment to the subject.
Location
University of Arkansas for Medical Sciences
Little Rick, Arkansas, United States
Status: Recruiting
Contact: Jose Penagaricano, MD - 501-686-7284 - PenagaricanoJoseA@uams.edu
Start Date
January 2013
Completion Date
January 2016
Sponsors
University of Arkansas
Source
University of Arkansas
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page