Status:
WITHDRAWN
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)
Lead Sponsor:
University of Arkansas
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 standa...
Detailed Description
This study will evaluate a combination therapy of paclitaxel and LDFRT. The paclitaxel will be commercially available drug product dispensed by a licensed pharmacist at UAMS. Radiotherapy will be deli...
Eligibility Criteria
Inclusion
- Subject 18 years of age and older, male or female, of all races and ethnicities.
- 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.
- Recurrence must have been confirmed via biopsy.
- Subject must have an ECOG performance status of 0, 1 or 2.
- Has undergone CT imaging within 21 days prior to treatment as part of routine care.
- Measurable disease by CT.
- Subject deemed likely to survive for at least 6 months.
- Subject is able and willing to provide written informed consent to participate in the study.
- 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.
- 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
- The tumor is not clearly shown on diagnostic imaging studies
- Subject is pregnant.
- Subject with known allergies/hypersensitivity to paclitaxel.
- 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.
- Subject with a planned surgical procedure within the next 30 days.
- Subject has distant metastasis (with the exception of single stable distant metastasis that does not decrease life expectancy to less than 6 months).
- Subject is of childbearing potential and will not use adequate contraceptive protection.
- Subject who is breastfeeding.
- Subject of childbearing potential who has a positive (+) urine pregnancy test.
- Subject has received treatment with an experimental drug or entered another clinical trial within the prior 30 days.
- Subject has received radiotherapy to the head and neck region within the prior 3 months.
- Subject is not willing or able to complete the visit requirements of this protocol.
- Peripheral neuropathy of any etiology.
- Any other condition that the PI feels will be an endangerment to the subject.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01820312
Start Date
January 1 2013
End Date
July 1 2015
Last Update
August 8 2016
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rick, Arkansas, United States, 72205