Squamous Cell CarcinomaPhase 2NCT01794845
Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
A Phase 2 study testing Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy in people with Squamous Cell Carcinoma and Head and Neck Cancer, run by University of Miami at 1 site in United States.
Trial summary
Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Squamous Cell Carcinoma, Head and Neck Cancer, Recurrent Disease
- What is being tested?
- Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2013to 7 Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥ 6 months following the end of the prior RT.
- The recurrence must have defined bi- or uni-dimensional measurements.
- Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).
- The patient must not be a candidate for surgical resection.
- Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.
- Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl, creatinine < 1.5 mg/dl within 3 weeks prior to registration.
- Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If > 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
- Patients must sign a study-specific informed consent form prior to study entry.
Who cannot join
- Distant metastases outside of the head and neck.
- Primary disease in the nasopharynx or the salivary gland.
- Other concurrent invasive malignancies.
- Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible).
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
- Pre-existing grade ≥ 2 peripheral sensory neuropathy
- Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
- Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug with formulated with Polysorbate 80.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.
Read the detailed description
The investigator's approach is based on the following reasons:
- Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest.
- LDFRT will render enhanced bax activation mediated mode of cell death.
- Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.
- The toxicity profile is expected to be minimal.
Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.
- Being tested
- Erbitux, Taxotere, Low Dose Fractionated Radiation Therapy
- Keywords
- SCCHN, Head and Neck Cancer, Squamous Cell Carcinoma, Recurrent
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErbituxDrug
Also called Cetuximab
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
TaxotereDrug
Also called Docetaxel
Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Low Dose Fractionated Radiation TherapyRadiation
Also called LDFRT
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Erbitux, Taxotere, LD Fractionated RT | Experimental | Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT) Receives: Drug: Erbitux; Drug: Taxotere; Radiation: Low Dose Fractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) of Participants
ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.
Measured: Up to 6 months from End of Treatment, about 9 months
Secondary outcomes (3)
Number of Study Participants Experiencing Treatment-Related Toxicity
Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity:
- Acute toxicity is defined as toxicity occurring within 90 days of start of therapy.
- Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy.
Measured: Up to 6 years
Estimated Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.
Measured: Up to 6 years
Estimated Overall Survival (OS)
Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study start3 Jun 2013
- Primary completion7 Jun 2016
- Study completion7 Jun 2016
Why it stopped: Early termination due to lack of efficacy (overall response)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Abramowitz, University of Miami
- Investigators
- Matthew C Abramowitz, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794845
- Sponsor's protocol ID
- 20090467
- Status last verified
- Mar 2017
- First submitted
- 14 Feb 2013
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
- ClinicalTrials.gov ID
- NCT01794845
- Acronym / sponsor ID
- 20090467
- Keywords
- SCCHN, Head and Neck Cancer, Squamous Cell Carcinoma, Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to lack of efficacy (overall response)
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 3 Jun 2013 (actual)
- Primary completion
- 7 Jun 2016 (actual)
- Study completion
- 7 Jun 2016 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 11 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.
Detailed description
The investigator's approach is based on the following reasons:
- Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest.
- LDFRT will render enhanced bax activation mediated mode of cell death.
- Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.
- The toxicity profile is expected to be minimal.
Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erbitux, Taxotere, LD Fractionated RT | Experimental | Drug: Erbitux, Drug: Taxotere, Radiation: Low Dose Fractionated Radiation TherapyErbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥ 6 months following the end of the prior RT.
- The recurrence must have defined bi- or uni-dimensional measurements.
- Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).
- The patient must not be a candidate for surgical resection.
- Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.
Key exclusion criteria (8 listed)
- Distant metastases outside of the head and neck.
- Primary disease in the nasopharynx or the salivary gland.
- Other concurrent invasive malignancies.
- Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible).
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
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 |
|---|---|---|
| ErbituxAlso: CetuximabErbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere. | Drug | Erbitux, Taxotere, LD Fractionated RT |
| TaxotereAlso: DocetaxelTaxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. | Drug | Erbitux, Taxotere, LD Fractionated RT |
| Low Dose Fractionated Radiation TherapyAlso: LDFRTLow-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy. | Radiation | Erbitux, Taxotere, LD Fractionated RT |
Primary outcome
Overall Response Rate (ORR) of Participants
Time frame: Up to 6 months from End of Treatment, about 9 months
ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.
3 secondary outcomes
Number of Study Participants Experiencing Treatment-Related Toxicity
Time frame: Up to 6 years
Estimated Progression-Free Survival (PFS)
Time frame: Up to 6 years
Estimated Overall Survival (OS)
Time frame: Up to 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Matthew C Abramowitz, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy in people with Squamous Cell Carcinoma and Head and Neck Cancer, run by University of Miami at 1 site in United States.
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 10 inclusion and 8 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) of Participants (time frame: Up to 6 months from End of Treatment, about 9 months). 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 11 May 2017.