Head and Neck NeoplasmsPhase 3NCT02183246
Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients
A Phase 3 study testing Porfiromycin and Radiotherapy in people with Head and Neck Neoplasms, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Porfiromycin and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Dec 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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.
About this study
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
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
- Being tested
- Porfiromycin, Placebo, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PorfiromycinDrug
PlaceboDrug
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Porfiromycin + Radiotherapy | Experimental | Not described Receives: Drug: Porfiromycin; Radiation: Radiotherapy |
| Placebo + Radiotherapy | Placebo comparator | Not described Receives: Drug: Placebo; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
Measured: week 4 and 8 post treatment, every 8 weeks until end of study
Maximum toxicity grades of Adverse Events (AE)
Measured: until 42 days after end of treatment
Time to non-accidental death
Measured: week 4 and 8 post treatment, every 8 weeks until end of study
Serum porfiromycin concentration-time profile
Measured: up to week 7
Secondary outcomes (7)
Death for any reason
Measured: 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
Measured: 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
Measured: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study
Loss of local or regional control
Measured: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study
Occurrence of Adverse Events
Measured: up to week 16
Significant changes in laboratory tests
Measured: up to week 7
Changes from baseline in Patients health related Quality of life-Questionnaires
Measured: week 1, 5, 7, 4 weeks post treatment, every 12 weeks until end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2000
- Primary completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183246
- Sponsor's protocol ID
- 1164.4
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02183246
- Acronym / sponsor ID
- 1164.4
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Dec 2000 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Porfiromycin + Radiotherapy | Experimental | Drug: Porfiromycin, Radiation: Radiotherapy |
| Placebo + Radiotherapy | Placebo comparator | Drug: Placebo, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porfiromycin | Drug | Porfiromycin + Radiotherapy |
| Placebo | Drug | Placebo + Radiotherapy |
| Radiotherapy | Radiation | Placebo + Radiotherapy, Porfiromycin + Radiotherapy |
Primary outcome
Time to Disease Progression
Time frame: week 4 and 8 post treatment, every 8 weeks until end of study
Maximum toxicity grades of Adverse Events (AE)
Time frame: until 42 days after end of treatment
Time to non-accidental death
Time frame: week 4 and 8 post treatment, every 8 weeks until end of study
Serum porfiromycin concentration-time profile
Time frame: up to week 7
7 secondary outcomes
Death for any reason
Time frame: 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
Time frame: 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
Time frame: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study
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
Occurrence of Adverse Events
Time frame: up to week 16
Significant changes in laboratory tests
Time frame: up to week 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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Related trials for Head and Neck Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Porfiromycin and Radiotherapy in people with Head and Neck Neoplasms, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Disease Progression (time frame: week 4 and 8 post treatment, every 8 weeks until end of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.