Head and Neck CancerPhase 2NCT01185171
Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer
A Phase 2 study testing ZD 1839 500mg in people with Head and Neck Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only). 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?
- ZD 1839 500mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2003to Aug 2018
- 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
- Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas, or lymphoepithelioma of the nasopharynx.
- Age 18 years or older.
- Patients with AJCC (6th edition, 2002) stage III or IV head and neck cancer.
- Patients with AJCC (6th edition, 2002) stage IV head and neck cancer. presenting with cervical lymph node metastasis of an unknown primary (i.e., TxN2 or TxN3) are also eligible.
- Prior to entry in the study, the resectability and alternative treatment options for each patient will be determined by a team composed of a head and neck surgeon, a radiation oncologist,and a medical oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. Each patient will be classified as having resectable or unresectable disease. The unequivocal demonstration of distant metastasis (M1) confers ineligibility.
- Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required. Individuals who are disease free at baseline after excisional biopsy or node dissection will be considered not evaluable for response assessment but are eligible.
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- No prior or radiotherapy.
- Prior surgical therapy will consist only of incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%.
- Patients must have normal organ and marrow function as defined below absolute neutrophil count (ANC) ≥ 1,500/μl platelets ≥ 100,000/μl total bilirubin within normal institutional limits aspartate aminotransferase (AST, SGOT)/ alanine aminotransferase (ALT, SGPT) ≤ 2.5 × institutional upper limit of normal alkaline phosphatase ≤ 2 × upper limit of normal creatinine within normal institutional limits
Who cannot join
- Unequivocal demonstration of metastatic disease (i.e. M1 disease).
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
- Any coexisting malignancy that would increase risk of toxicity, interfere with interpretation of toxicity, or is associated with a median survival of less than 24 months.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or St.John's Wort.
- Treatment with an investigational drug within 30 days before Day 1 of trial treatment.
- Incomplete healing from previous surgery.
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- Pregnancy or breast feeding (women of child-bearing potential). Patients should be advised to use effective contraception as appropriate.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, Cremophor EL, carboplatin, 5 FU, or hydroxyurea.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician.
- Patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
- No patients with severe baseline neurologic deficits (> grade II neuropathy) will be treated with induction chemotherapy.
- Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60653
About this study
Official title: Ph II Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer
The purpose of this study is to explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only).
- Conditions
- Head and Neck Cancer
- Being tested
- ZD 1839 500mg
- Keywords
- Larynx, Lip, Oral Cavity and Pharynx
- Medical subject headings
- Head and Neck Neoplasms, Laryngeal Diseases, Lymphoid Interstitial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD 1839 500mgDrug
Optional Induction chemotherapy:
Carboplatin and paclitaxel combination will be administered for 2 cycles of 4 weeks duration each. Paclitaxel: 100 mg/m2 in 500 ml of dextrose 5% in water over 3hrs. Carboplatin: Start after completion of paclitaxel on Day 1 AUC 6 (creatinine clearance [CC] + 25). Administered in 100 ml of normal saline over 30min after completion of paclitaxel.
Resume chemotherapy C2 on D29. ZD1839: 500mg PO QD from D1 of C1 of chemoradiotherapy, uninterrupted until disease progression. Chemotherapy should be administered during all 5 weeks of radiotherapy. P.M.:Start hydroxyurea at 500 mg PO q 12hrs × 6 days. The first daily dose of hydroxyurea on Days 1 through 5 is given 2 hours prior to the first fraction of daily radiotherapy. P.M.:Start continuous infusion of 5-FU at 600 mg/m2/day × 5D. Days 1 through 5: Radiation therapy is administered twice daily at 150 cGy ZD1839 will be administered from day 1 to 14 of every chemoradiotherapy cycle.
| Study group | Role | What they receive |
|---|---|---|
| ZD1839 500mg by mouth (po) daily | Experimental | Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone. Receives: Drug: ZD 1839 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate Achieved 1 Month After Concurrent Chemotherapy and Radiation Treatment
To explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only).
Measured: 1 month
Secondary outcomes (3)
4 Year Overall Survival
Percentage of patients who survived 4 years or more
Measured: 0.3 to 4.7 years
4 Year Progression Free Survival
Percentage of patients who survived without progressive disease 4 years or more
Measured: 0.3 to 4.7 years
4 Year Disease Specific Survival
Percentage of patients who did not die by the disease within 4 years
Measured: 0.3 to 4.7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study start27 Jan 2003
- Primary completionJul 2018
- Study completionAug 2018
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.
- More trials run by University of ChicagoThe 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Everett Vokes, MD, Principal investigator, The University of Chicago Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185171
- Sponsor's protocol ID
- 12019A
- Status last verified
- May 2023
- First submitted
- 18 Aug 2010
- Last updated
- 11 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph II Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer
- ClinicalTrials.gov ID
- NCT01185171
- Acronym / sponsor ID
- 12019A
- Conditions
- Head and Neck Cancer
- Keywords
- Larynx, Lip, Oral Cavity and Pharynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 27 Jan 2003 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Posted 2 Jun 2020
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 explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZD1839 500mg by mouth (po) daily | Experimental | Drug: ZD 1839 500mgSingle arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas, or lymphoepithelioma of the nasopharynx.
- Age 18 years or older.
- Patients with AJCC (6th edition, 2002) stage III or IV head and neck cancer.
- Patients with AJCC (6th edition, 2002) stage IV head and neck cancer. presenting with cervical lymph node metastasis of an unknown primary (i.e., TxN2 or TxN3) are also eligible.
- Prior to entry in the study, the resectability and alternative treatment options for each patient will be determined by a team composed of a head and neck surgeon, a radiation oncologist,and a medical oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. Each patient will be classified as having resectable or unresectable disease. The unequivocal demonstration of distant metastasis (M1) confers ineligibility.
Key exclusion criteria (13 listed)
- Unequivocal demonstration of metastatic disease (i.e. M1 disease).
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
- Any coexisting malignancy that would increase risk of toxicity, interfere with interpretation of toxicity, or is associated with a median survival of less than 24 months.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or St.John's Wort.
- Treatment with an investigational drug within 30 days before Day 1 of trial treatment.
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 |
|---|---|---|
| ZD 1839 500mgOptional Induction chemotherapy: Carboplatin and paclitaxel combination will be administered for 2 cycles of 4 weeks duration each. Paclitaxel: 100 mg/m2 in 500 ml of dextrose 5% in water over 3hrs. Carboplatin: Start after completion of paclitaxel on Day 1 AUC 6 (creatinine clearance [CC] + 25). Administered in 100 ml of normal saline over 30min after completion of paclitaxel. Resume chemotherapy C2 on D29. ZD1839: 500mg PO QD from D1 of C1 of chemoradiotherapy, uninterrupted until disease progression. Chemotherapy should be administered during all 5 weeks of radiotherapy. P.M.:Start hydroxyurea at 500 mg PO q 12hrs × 6 days. The first daily dose of hydroxyurea on Days 1 through 5 is given 2 hours prior to the first fraction of daily radiotherapy. P.M.:Start continuous infusion of 5-FU at 600 mg/m2/day × 5D. Days 1 through 5: Radiation therapy is administered twice daily at 150 cGy ZD1839 will be administered from day 1 to 14 of every chemoradiotherapy cycle. | Drug | ZD1839 500mg by mouth (po) daily |
Primary outcome
Complete Response Rate Achieved 1 Month After Concurrent Chemotherapy and Radiation Treatment
Time frame: 1 month
To explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only).
3 secondary outcomes
4 Year Overall Survival
Time frame: 0.3 to 4.7 years
4 Year Progression Free Survival
Time frame: 0.3 to 4.7 years
4 Year Disease Specific Survival
Time frame: 0.3 to 4.7 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Chicago Comprehensive Cancer Center Web pageLink 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.
Everett Vokes, MD principal investigator
The University of Chicago Medical Center
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 ZD 1839 500mg in people with Head and Neck Cancer, run by University of Chicago 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 13 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 11 May 2023. 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 2 Jun 2020). 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?
Complete Response Rate Achieved 1 Month After Concurrent Chemotherapy and Radiation Treatment (time frame: 1 month). 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 2023.