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

NCT02183246 | Terminated Phase 3

• 1 other identifier: 1164.4
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• Time to Disease Progression

  week 4 and 8 post treatment, every 8 weeks until end of study

• Maximum toxicity grades of Adverse Events (AE)

  until 42 days after end of treatment

• Time to non-accidental death

  week 4 and 8 post treatment, every 8 weeks until end of study

• Serum porfiromycin concentration-time profile

  up to week 7

Secondary Outcomes (7)

• Death for any reason

  4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study

• Loss of local or regional control, distant metastasis or death for any reason

  4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study

• Loss of local or regional control or distant metastasis

  4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study

• Loss of local or regional control

  4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study

• Occurrence of Adverse Events

  up to week 16

Study Arms (2)

Porfiromycin + Radiotherapy

EXPERIMENTAL

Drug: Porfiromycin; Radiation: Radiotherapy

Placebo + Radiotherapy

PLACEBO COMPARATOR

Drug: Placebo; Radiation: Radiotherapy

Interventions

Porfiromycin DRUG

Porfiromycin + Radiotherapy

Placebo DRUG

Placebo + Radiotherapy

Radiotherapy RADIATION

Placebo + Radiotherapy; Porfiromycin + Radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Granulocyte (neutrophil) count of \< 1,500/cubic millimeters (mm3)
• Platelets \< 75,000/mm3
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Porfiromycin; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2000
• Primary Completion: December 1, 2000
• Last Updated: July 8, 2014

Record last verified: 2014-07