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Safety and Efficacy Study of P276-00 in Combination With Radiation in Subjects With Advanced Head and Neck Cancer

NCT00899054 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-11-22

No results posted yet for this study

Summary

The purpose of this study is to identify a dose of P276-00 that can be safely administered along with Radiation and to examine safety and efficacy of the combination in treatment of advanced head and neck cancer.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

P276-00

P276-00 will be administered at different dose levels: level 1: 100 mg/m2/day dose level 2: 140 mg/m2/day dose level 3: 185 mg/m2/day to be given from day 1 to day 5 every 21 days for 2 cycle. P276-00 will be administered as intravenous infusion in 200 ml 5% Dextrose over 30 min from days 1 to 5 per 21 day cycle for two cycles.

RADIATION

External beam radiotherapy (EBRT)

All subjects will receive external beam radiotherapy (EBRT)by using standard conventional fractionation i.e. 2 Gy per day for 5 days a week for a total radiation dose of 60 Gy over 6 weeks followed by upto 10 additional Gy if required.

Sponsors & Collaborators

  • Piramal Enterprises Limited

    lead INDUSTRY

Principal Investigators

  • Kirushna Kumar, MD, RT · Meenakshi Mission Hospital & Research Centre, Madurai, India

  • Raj Nagarkar, MS · Curie Manavata Cancer Center, Nashik, India

  • Subhashini John, MD, DMRT · Christian Medical College, Vellore, India

  • Balaji Shewalkar, MD, DNB · Government Medical College, Aurangabad, India

  • M. Nagarajan, MD, DNB · V. N. Cancer Centre, GKNM Hospital, Coimbatore, India

  • Naresh Somani, DM · Bhagwan Mahawir Cancer Hospital & Research Centre, Jaipur, India

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-01-31
Completion
2012-11-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00899054 on ClinicalTrials.gov