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

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ClinicalTrials.gov Identifier: NCT02183246
Recruitment Status : Terminated
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Porfiromycin Drug: Placebo Radiation: Radiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Double-Blind, Randomized, Placebo-Controlled Study of Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients
Study Start Date : May 2000
Actual Primary Completion Date : December 2000

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Porfiromycin + Radiotherapy Drug: Porfiromycin
Radiation: Radiotherapy
Placebo Comparator: Placebo + Radiotherapy Drug: Placebo
Radiation: Radiotherapy



Primary Outcome Measures :
  1. Time to Disease Progression [ Time Frame: week 4 and 8 post treatment, every 8 weeks until end of study ]
  2. Maximum toxicity grades of Adverse Events (AE) [ Time Frame: until 42 days after end of treatment ]
  3. Time to non-accidental death [ Time Frame: week 4 and 8 post treatment, every 8 weeks until end of study ]
  4. Serum porfiromycin concentration-time profile [ Time Frame: up to week 7 ]

Secondary Outcome Measures :
  1. Death for any reason [ Time Frame: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study ]
  2. Loss of local or regional control, distant metastasis or death for any reason [ Time Frame: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study ]
  3. Loss of local or regional control or distant metastasis [ Time Frame: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study ]
  4. Loss of local or regional control [ Time Frame: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study ]
  5. Occurrence of Adverse Events [ Time Frame: up to week 16 ]
  6. Significant changes in laboratory tests [ Time Frame: up to week 7 ]
  7. Changes from baseline in Patients health related Quality of life-Questionnaires [ Time Frame: week 1, 5, 7, 4 weeks post treatment, every 12 weeks until end of study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183246    
Other Study ID Numbers: 1164.4
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Porfiromycin
Antibiotics, Antineoplastic
Antineoplastic Agents