Head and Neck CancerPhase 2NCT00242762
ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer
A Phase 2 study testing ZD1839 (IRESSA™), Docetaxel and Cisplatin in people with Head and Neck Cancer, run by AstraZeneca at 4 sites in Spain.
Trial summary
The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response [CR] and partial response [PR]) at study closure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- ZD1839 (IRESSA™), Docetaxel and Cisplatin
- How many people
- 36 participants
- Where
- 4 sitesSpain
- Study dates
- Jul 2003to Mar 2006
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 and 70 years, inclusive
- Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN
- Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx
- At least one uni-dimensionally measurable lesion according to the RECIST
- World Health Organisation (WHO) performance status (PS) of 0 or 1
- No previous chemotherapy for recurrent or metastatic disease
- Before subject registration a quality of life questionnaire should be completed
Who cannot join
- Previous chemotherapy for recurrent or metastatic disease
- Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
Show all 17Show fewer
- Absolute neutrophil count (ANC) less than 1.5 x109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 10 g/dl
- Serum bilirubin greater than the upper limit of the reference range (ULRR)
- Serum creatinine greater than 1.5 mg/dl despite adequate rehydration
- Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR or alkaline phosphatase (ALP) greater than 2.5 times the ULRR
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- Pregnancy or breast feeding (women of child-bearing potential)
- Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John's Wort
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
- 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
4 sites in 1 country.
Spain4 sites
Research Facility
Granada
Research Facility
Madrid
Research Facility
Murcia
Research Site
Seville
About this study
Official title: A Phase II Study to Evaluate the Safety and Efficacy of the Combination of ZD1839 (IRESSA™), Docetaxel and Cisplatin in Subjects With Recurrent and/or Metastatic Head and Neck Cancer
The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response [CR] and partial response [PR]) at study closure.
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Neoplasms, Cancer of Head and Neck, Head and Neck Cancer, Head Cancer, Neck Cancer
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)
Secondary outcomes (4)
PFS
Overall survival
Incidence of DLT during the first cycle of study treatment
Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startJul 2003
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Spain Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242762
- Sponsor's protocol ID
- 1839IL/0504
- Status last verified
- Jan 2011
- First submitted
- 20 Oct 2005
- Last updated
- 27 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety and Efficacy of the Combination of ZD1839 (IRESSA™), Docetaxel and Cisplatin in Subjects With Recurrent and/or Metastatic Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00242762
- Acronym / sponsor ID
- 1839IL/0504
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Neoplasms, Cancer of Head and Neck, Head and Neck Cancer, Head Cancer, Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 21 Oct 2005 (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.
The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response [CR] and partial response [PR]) at study closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 18 and 70 years, inclusive
- Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN
- Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx
- At least one uni-dimensionally measurable lesion according to the RECIST
- World Health Organisation (WHO) performance status (PS) of 0 or 1
Key exclusion criteria (17 listed)
- Previous chemotherapy for recurrent or metastatic disease
- Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
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 |
|---|---|---|
| ZD1839 (IRESSA™) | Drug | – |
| Docetaxel | Drug | – |
| Cisplatin | Drug | – |
Primary outcome
Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)
4 secondary outcomes
PFS
Overall survival
Incidence of DLT during the first cycle of study treatment
Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
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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.
AstraZeneca Spain Medical Director, MD study director
AstraZeneca
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZD1839 (IRESSA™), Docetaxel and Cisplatin in people with Head and Neck Cancer, run by AstraZeneca at 4 sites in Spain.
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 17 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 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST). 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 27 Jan 2011.