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A Phase II Clinical Trial to Study the Efficacy and Safety of a New Drug P276-00 in Treatment of Recurrent and/or Locally Advanced Head and Neck Cancer

NCT00824343 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2013-07-10

No results posted yet for this study

Summary

This is a single arm phase II trial to study the efficacy and safety of a Cdk inhibitor P276-00 in the treatment of squamous cell carcinoma of head and neck. Patients with recurrent or metastatic disease that is unresectable and incurable by radiation will be enrolled. Thirty eight evaluable patients need to be enrolled in the study. All patients will receive protocol treatment i.e. P276-00 as an intravenous infusion from day 1 to day 5 and from day 8 to day 12 in each 21 day cycle till progression of disease or unacceptable toxicity. Safety evaluations by means of recording vitals, physical examination and lab investigations like hematology and clinical chemistry will be undertaken at regular intervals in each cycle. Tumor measurements by spiral CT scan will be undertaken at baseline and at the end of every 2 cycles for response evaluation by RECIST criteria. All patients will be followed up for survival status till one year of cycle 1 day 1.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

P276-00

For patients to be recruited in amended protocol, P276-00 will be administered to all subjects at a dose of 144 mg/m2/day as i.v infusion in 200 ml of 5% dextrose over 30 minutes from day 1 to day 5 and from day 8 to day 12 in each 21 day cycle. Subjects will receive treatment till progression of disease or till unacceptable toxicity. All subjects will be followed up for survival status till one year of initiation of protocol treatment.

Sponsors & Collaborators

  • Piramal Enterprises Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Ajay Mehta · Director and Onco-Surgeon, Central India Cancer Research Institute, Nagpur

  • Dr. M S Vishveshwara · Radiation Oncologist, Bharat Hospital Institute of Oncology, Mysore

  • Dr. Sanjeev Misra · Oncosurgeon, Department of Surgical Oncology, CSM Medical University, Lucknow

  • Dr. Rejnish Kumar · Associate Professor, Regional Cancer Centre, Trivandram

  • Dr. Lalit Mohan Sharma · Consultant Medical Oncologist, Bhagwan Mahavir Cancer Hospital and Research Centre, Jaipur

  • Dr. Maheboob Basade · Medical Oncologist, Jaslok Hospital, Mumbai

  • Dr. Nilesh Lokeshwar, MD, DM · Medical Oncologist

  • Dr. Chetan Deshmukh, MD, DM · Medical Oncologist, Deenanath Mangeshkar Hospital and Research Centre, Pune, India

  • Dr. M Nagarajan, MD · Radiation Oncologist, V. N. Cancer Centre, GKNM Hospital, Coimbatore, 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
2008-09-30
Primary Completion
2011-04-30
Completion
2013-06-30

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 NCT00824343 on ClinicalTrials.gov