NCT01172470
Completed
Phase 2
Phase II Trial of Pemetrexed-Based Induction Chemotherapy Followed by Concomitant Chemoradiotherapy in Previously Irradiated Head and Neck Cancer Patients
ConditionsHead and Neck Cancer
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Primary objective is to determine 1-year survival of previously irradiated Head/Neck Cancer patients with loco-regional recurrent disease treated with induction chemotherapy with pemetrexed and gemcitabine followed by concomitant pemetrexed, carboplat
Overview
Brief Summary
The purpose of this study is to determine 1-year survival of previously irradiated Head and Neck cancer (HNC) patients with loco-regional recurrent disease treated with induction chemotherapy with pemetrexed and gemcitabine followed concomitant pemetrexed, carboplatin and daily radiotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All previously irradiated patients with recurrent head and neck cancer with no clinically measurable distant disease or those patients in whom distant disease was of low volume and local and regional palliation is clinically warranted. Low volume metastatic disease is defined as asymptomatic or minimally symptomatic disease that, according to physician judgment and without therapy for locoregionally recurrent disease, is unlikely to effect the subject's quality or quantity of life.
- •Histologic or cytological documentation of recurrent head and neck cancer requiring regional therapy.
- •Prior radiation therapy completed \> 4 months before to study entry, if patients have recovered from all side effects grade
- •Predominance of disease that is amenable to radiotherapy.
- •Measurable disease prior to induction chemotherapy.
- •Age \>18 years
- •Life expectancy of greater than 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky \> 70%).
- •Patients must have normal organ and marrow function as defined below:
- •Leukocytes \>3,000/ul Absolute neutrophil count \>1,500/ul Platelets \>100,000/ul Total bilirubin \< 1.5X institutional upper limit of normal AST (SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal Creatinine Clearance (CrCl) \> 45 mL/min
Exclusion Criteria
- •Previously untreated patients are not eligible
- •Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- •Patients may not be receiving any other investigational agents.
- •History of allergic reactions attributed to compounds of similar chemical composition agents used in the study.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Outcomes
Primary Outcomes
Primary objective is to determine 1-year survival of previously irradiated Head/Neck Cancer patients with loco-regional recurrent disease treated with induction chemotherapy with pemetrexed and gemcitabine followed by concomitant pemetrexed, carboplat
Time Frame: 1-3 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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