A Study to Assess Radiation Induced Mucositis in Patients of Head and Neck Cancer Administered Chemo-Radiation With or Without P276-00

NCT01903018 | Completed Phase 2

• 1 other identifier: P276-00/64/11
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 7

Brief Summary

A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Conditions

Radiation Induced Mucositis in Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Number of severe Radiation Induced Mucositis (WHO grade >=3)

  For Phase2, to assess the incidence of severe (WHO Grade \>=3) Radiation Induced Mucositis (RIM)occurring up to a cumulative radiation dose of 66 Gray (Gy) based on the WHO mucositis scale in subjects with locally advanced squamous cell carcinoma of the head and neck (SCCHN) treated with cisplatin and radiotherapy plus P276-00 * For Phase 3 * To assess and compare the incidence of severe (WHO Grade\>=3) Radiation Induced Mucositis (RIM) occurring up to a cumulative radiation dose of 54 Gy based on the WHO mucositis scale * To assess and compare the incidence of severe (WHO Grade\>=3) RIM occurring up to a cumulative radiation dose of 66 Gy based on the WHO mucositis scale in subjects with locally advanced SCCHN treated with cisplatin and radiotherapy plus P276-00 or cisplatin and radiotherapy (the two treatment arms).

  Week 15

Secondary Outcomes (4)

• Time to onset of severe RIM (WHO Grade ≥ 3)

  Week 15

• Duration of severe RIM (WHO Grade>=3)

  Week 15

• Progression-Free Survival (PFS)

  1year

• Overall Survival (OS)

  1year

Study Arms (1)

P276-00

EXPERIMENTAL

Drug: P276-00; Radiation: Radiation Therapy; Drug: Cisplatin

Interventions

P276-00 DRUG

P276-00

Radiation Therapy RADIATION

P276-00

Cisplatin DRUG

P276-00

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and willing to give an informed consent for the study.
• Pathologically (histologically or cytologically) confirmed (from primary tumor and/or lymph nodes), non-metastatic diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx eligible for treatment with concomitant chemoradiation as first-line treatment; subjects with a history of surgical management are not eligible
• Have a plan to receive a continuous course of radiation (3DRT or IMRT) as single daily fractions of 2.0 Gy, with a cumulative radiation dose between 66 and 70 Gy. Planned radiation treatment fields must include at least 2 oral sites (maxillary or mandibular labial mucosa, right or left buccal mucosa, right or left floor of the mouth, ventral tongue, right or left lateral tongue, or soft palate), with each site receiving more than equal to 50 Gy
• Have a plan to receive a standard cisplatin regimen administered weekly (30 to 40 mg/m2)
• Have an Eastern Co-operative Oncology Group (ECOG) performance status less than equal to 2
• Males or females aged 18 years or older
• Pre-treatment dental procedures must be completed with recovery and the prophylactic insertion of gastric feeding tubes (if planned) prior to entry into the study
• Adequate bone marrow function measured within two weeks prior to enrollment based upon CBC/differential, defined as follows:
• Absolute neutrophil count (ANC) more than equal to 1,500 cells/mm3
• Platelets more than equal to 100,000 cells/mm3
• Hemoglobin (Hb) more than equal to 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hb more than equal to 8.0 g/dl prior to the start of RT is acceptable)
• Adequate hepatic function measured within two weeks prior to enrollment defined as follows
• Bilirubin less than equal to 1.5 mg/dl
• AST less than equal to 2 times ULN
• ALT less than equal to 2 times ULN

You may not qualify if:

• Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
• Metastatic disease (M1) Stage IVC as per the AJCC, 7th edition
• Prior radiation to the head and neck
• Have undergone induction CT
• History of malignant tumors other than HNC (except non-melanoma skin cancer) unless disease free for a minimum of 3 years
• Severe co-morbidity, defined as:
• Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV
• Acute myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring systemic antibiotics at the time of enrollment
• Subjects known to be seropositive for human immunodeficiency virus (HIV) or subjects with Acquired Immune Deficiency Syndrome (AIDS), known current acute or chronic Hepatitis B, known Hepatitis C (antigen positive), or hepatic cirrhosis
• Subjects with active tuberculosis
• Collagen vascular disease, such as scleroderma, as this is thought to predispose subjects to increased risk for radiation-associated toxicities
• Have used any other investigational drug therapy within 1 month prior to Day 1 of study drug administration or non-recovery (to Grade less than equal to 1) from adverse effects of the investigational agent received prior to this period
• Prior allergic reaction to any of the agents administered during the course of treatment
• Have QTcF more than equal to 450 msec at screening

Sponsors & Collaborators

• Piramal Enterprises Limited: lead

Study Sites (7)

Bharat Cancer Hospital & Research Institute

Surat, Gujarat, 395010, India

Location

Sri Venkateshwara Hospitals

Bangalore, Karnataka, 560068, India

Location

Mazumdar Shaw Cancer Center

Bangalore, Karnataka, 560099, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Curie Manavta Cancer Centre

Nashik, Maharashtra, 422004, India

Location

Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Meenakshi Mission Hosp. & Res. Centre

Madurai, Tamil Nadu, 625107, India

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

P276-00; Radiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Dr.Sarbani Ghosh Laskar, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 19, 2013
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

IN (7)