Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients

NCT ID: NCT02183246

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-31

Brief Summary

Determination of efficacy and safety of porfiromycin versus placebo as an adjuvant to radiotherapy in postoperative head and neck a cancer patients as well as assessment of population pharmacokinetic parameters.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Porfiromycin + Radiotherapy

Group Type: EXPERIMENTAL

Porfiromycin

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Placebo + Radiotherapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Interventions

Porfiromycin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Male or female postoperative radical neck surgery patients with histologically proven Stage III or IV (without distant metastases) epidermoid (squamous cell) carcinoma of the head and neck limited to the following locations as defined by the American Joint Commission (AJC): lip and oral cavity, pharynx, or larynx.
• Postoperative radical patients whose specimen had a) microscopic positive tumor cell margins (< 2mm from surgical margin) or b) extranodal capsular spread (perineural-vascular embolization) or c) two or more positive nodes
• Postoperative radical neck patients must have received Radiotherapy (RT).
• Performance status of ≥ 70 on the Karnofsky Performance Score (KPS) at screening.
• Patients ≥ 18 years of age
• Patients must have provided written informed consent prior to participation in the trial.
• Patients must have demonstrated an educational level and a degree of understanding such that they could communicate effectively with the investigator.

Exclusion Criteria

• Patients that received any prior chemotherapy including mitomycin-C or porfiromycin.
• Treatment with granulocyte, granulocyte-macrophage stimulating factor (G-CSF, GM-CSF) or Interleukin-11 within 30 days prior to start of RT.
• RT within the treatment field for any malignancy within the past five years.
• Patients who had any gross (visible or palpable) residual disease left after surgery.
• Patients who met any of the following clinical laboratory criteria upon screening:

1. Granulocyte (neutrophil) count of < 1,500/cubic millimeters (mm3)

2. Platelets < 75,000/mm3

3. Prothrombin time (PT) and partial thromboplastin time (PTT) > 1.5 times the upper limit of normal (ULN) in seconds.

• Women who were pregnant or nursing.
• Women of childbearing potential who were unwilling to utilise a medically acceptable method of contraception (oral contraceptives, intrauterine devices, diaphragm or subdermal implants eg: Norplant®).
• Other malignancies active within the past five years (other than basal or squamous cell carcinomas of the skin outside the planned radiation portals, or in situ carcinoma of the cervix).
• The presence of more than one primary tumor or presence of distant metastases.
• The presence of any other life-threatening illness, such a severe chronic lung, liver, or heart disease that would be expected to be fatal within five years, regardless of the patient's cancer status.
• Patients who participated in a clinical trial with another investigational drug or treatment 30 days prior to screening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1164.4

Identifier Type: -

Identifier Source: org_study_id