Head and Neck CancerPhase 2NCT00304278
Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
A Phase 2 study testing Erlotinib (Tarceva), Intra-arterial Cisplatin (PLAT) and Radiation Therapy (RAD) in people with Head and Neck Cancer, run by Southern Illinois University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with Head and Neck cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Erlotinib (Tarceva), Intra-arterial Cisplatin (PLAT) and Radiation Therapy (RAD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed Stage III-IV disease comprised of T3 or T4 N0-2 lesions of the oral cavity, oropharynx, hypopharynx, and larynx.
- No previous radiation therapy or chemotherapy.
- No evidence of distant metastatic disease.
- Age > 18.
- Karnofsky performance status of > 60 (ECOG 2).
- ANC > 1000, platelets > 100,000, calculated or 24-hour creatinine clearance > 60.
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- Study-specific informed consent form.
- Protocol treatment must begin < 8 weeks of diagnostic biopsy.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients with surgically cured secondary malignancy who have been disease free > 5 years are eligible.
Who cannot join
- Radiologic evidence of bone destruction.
- Previous or concurrent head and neck primaries.
- Prior surgery to study site other than biopsy.
- Patients receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because treatments and agents have the potential for teratogenic or abortifacient effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- History of a prior or concomitant malignancy (other than carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin).
Trial locations and contacts
1 site in 1 country.
United States1 site
Simmons Cooper Cancer Institute/SIU School of Medicine
Springfield, Illinois, 62702
About this study
Official title: Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with Head and Neck cancer
Read the detailed description
Head and neck malignancies represent a group of epidermoid tumors that arise from the epithelial lining of the mouth, pharynx, and larynx. Three modalities of therapy have established roles in the treatment of carcinoma of the head and neck: chemotherapy, radiation therapy (XRT), and surgery. The choice of modality depends upon many factors such as the site and extent of the primary lesion, the likelihood of complete surgical resection, the presence of lymph node metastases, etc. Traditionally, smaller lesions (stage T1-T2) are effectively treated either, by surgical excision or irradiation whereas more advanced disease (stage III-IV) is treated with combined surgery and XRT. The subsequent morbidity related to extensive surgery is a major problem among survivors. Clearly, there is a need to develop therapeutic strategies for patients with advanced head and neck cancer with more effective approaches employing non-surgical modalities.
Our hypothesis is that head and neck cancers are resistant to apoptosis from DNA damage induced by radiation and chemotherapy. This resistance is mediated by EGFR overexpression which results in downstream activation of cell survival signals, such as AKT, and may be overcome when Erlotinib (Tarceva) is co-administered with RADiation and cisPLATin (intraarterial chemotherapy).
- Conditions
- Head and Neck Cancer
- Being tested
- Erlotinib (Tarceva), Intra-arterial Cisplatin (PLAT), Radiation Therapy (RAD)
- Keywords
- Head and Neck Cancer, Erlotinib, RADPLAT
- 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.
Erlotinib (Tarceva)Drug
Also called Tarceva
150 mg daily X 7 weeks
Intra-arterial Cisplatin (PLAT)Drug
Also called Cisplatin
1 dose (150 mg/sq) per week X 4 weeks
Radiation Therapy (RAD)Radiation
5 days per week X 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| RADPLAT and Tarceva | Experimental | All patients will receive RADPLAT and Tarceva:
Drug: Erlotinib (Tarceva)
150 mg daily X 7 weeks
Other Names:
Tarceva
Drug: Intra-arterial Cisplatin (PLAT)
1 dose (150 mg/sq) per week X 4 weeks
Other Names:
Cisplatin
Radiation: Radiation Therapy (RAD)
5 days per week X 7 weeks Receives: Drug: Erlotinib (Tarceva); Drug: Intra-arterial Cisplatin (PLAT); Radiation: Radiation Therapy (RAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete and Partial Response Using RECIST Criteria
Complete and Partial Response as defined by RECIST 1.0. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
Measured: 17 weeks
Secondary outcomes (2)
Survival Post Treatment
Overall Survival of patients treated with Tarceva combined with RADPLAT.
Measured: 22 months
Disease Free Survival at 1year
Subject free of disease at 1 year post treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2015
- Study completionDec 2015
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 Head and Neck CancerStudies of the same condition, open and under way.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Krishna Rao, MD, PhD, Principal investigator, SIU School of MedicineThomas Robbins, MD, Principal investigator, Simmons Cancer Institute at SIU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304278
- Sponsor's protocol ID
- RAO-OSI-3601S
- Other IDs
- OSI 3601s
- Status last verified
- May 2026
- First submitted
- 16 Mar 2006
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
- ClinicalTrials.gov ID
- NCT00304278
- Acronym / sponsor ID
- RAO-OSI-3601S
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Erlotinib, RADPLAT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Study start
- Mar 2006
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Posted 27 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with Head and Neck cancer
Detailed description
Head and neck malignancies represent a group of epidermoid tumors that arise from the epithelial lining of the mouth, pharynx, and larynx. Three modalities of therapy have established roles in the treatment of carcinoma of the head and neck: chemotherapy, radiation therapy (XRT), and surgery. The choice of modality depends upon many factors such as the site and extent of the primary lesion, the likelihood of complete surgical resection, the presence of lymph node metastases, etc. Traditionally, smaller lesions (stage T1-T2) are effectively treated either, by surgical excision or irradiation whereas more advanced disease (stage III-IV) is treated with combined surgery and XRT. The subsequent morbidity related to extensive surgery is a major problem among survivors. Clearly, there is a need to develop therapeutic strategies for patients with advanced head and neck cancer with more effective approaches employing non-surgical modalities.
Our hypothesis is that head and neck cancers are resistant to apoptosis from DNA damage induced by radiation and chemotherapy. This resistance is mediated by EGFR overexpression which results in downstream activation of cell survival signals, such as AKT, and may be overcome when Erlotinib (Tarceva) is co-administered with RADiation and cisPLATin (intraarterial chemotherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RADPLAT and Tarceva | Experimental | Drug: Erlotinib (Tarceva), Drug: Intra-arterial Cisplatin (PLAT), Radiation: Radiation Therapy (RAD)All patients will receive RADPLAT and Tarceva: Drug: Erlotinib (Tarceva) 150 mg daily X 7 weeks Other Names: Tarceva Drug: Intra-arterial Cisplatin (PLAT) 1 dose (150 mg/sq) per week X 4 weeks Other Names: Cisplatin Radiation: Radiation Therapy (RAD) 5 days per week X 7 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histologically or cytologically confirmed Stage III-IV disease comprised of T3 or T4 N0-2 lesions of the oral cavity, oropharynx, hypopharynx, and larynx.
- No previous radiation therapy or chemotherapy.
- No evidence of distant metastatic disease.
- Age > 18.
- Karnofsky performance status of > 60 (ECOG 2).
Key exclusion criteria (8 listed)
- Radiologic evidence of bone destruction.
- Previous or concurrent head and neck primaries.
- Prior surgery to study site other than biopsy.
- Patients receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
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 |
|---|---|---|
| Erlotinib (Tarceva)Also: Tarceva150 mg daily X 7 weeks | Drug | RADPLAT and Tarceva |
| Intra-arterial Cisplatin (PLAT)Also: Cisplatin1 dose (150 mg/sq) per week X 4 weeks | Drug | RADPLAT and Tarceva |
| Radiation Therapy (RAD)5 days per week X 7 weeks | Radiation | RADPLAT and Tarceva |
Primary outcome
Number of Participants With Complete and Partial Response Using RECIST Criteria
Time frame: 17 weeks
Complete and Partial Response as defined by RECIST 1.0. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
2 secondary outcomes
Survival Post Treatment
Time frame: 22 months
Disease Free Survival at 1year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- official website of the SimmonsCooper Cancer Institute at SIULink provided by the sponsor.
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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.
Krishna Rao, MD, PhD principal investigator
SIU School of Medicine
Thomas Robbins, MD principal investigator
Simmons Cancer Institute at SIU
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 Erlotinib (Tarceva), Intra-arterial Cisplatin (PLAT) and Radiation Therapy (RAD) in people with Head and Neck Cancer, run by Southern Illinois University 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: finished, as of the sponsor's last update on 8 Jun 2026. 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 27 Jul 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?
Number of Participants With Complete and Partial Response Using RECIST Criteria (time frame: 17 weeks). 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 Jun 2026.