Lung CancerPhase 1/2NCT00390429
Docetaxel and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors
A Phase 1/2 study testing docetaxel and erlotinib hydrochloride in people with Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by University of California, Davis at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- docetaxel and erlotinib hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Aug 2012
- Phase
- Phase 1/2
- 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
- For the phase II portion patients must have cytologically or histologically proven NSCLC. (Completed 12/1/04 - For the phase I portion of the study patients must have cytologically or histologically proven advanced solid tumors for which there is no standard therapy of curative intent).
- For the phase II portion patients must have disease that has progressed or recurred after treatment with platinum based therapy. Patients that have stable disease after front line platinum based therapy is also eligible.
- No more than 1 previous treatment for metastatic disease is allowed for the phase II portion. (Completed 12/1/04 - Any number of prior chemotherapy regimens for metastatic disease are allowed for the phase I portion).
- Patients must have measurable disease by RECIST criteria. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy. (Completed 12/1/04 - Patients with evaluable disease may be included in the phase I portion of the trial.
- Patients must be 18 years of age or older.
- Patients must have a performance status of 0-1 for the phase II portion of the trial. (Completed 12/1/04 - performance status of 0-2 for is allowed for the phase I portion of study
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- Patients must have an estimated survival of at least 3 months.
- Any prior chemotherapy that patients have received has to have been completed at least 4 weeks prior to start of OSI-774/Docetaxel. For prior mitomycin chemotherapy a 6-week interval is required. Prior radiation must have been completed at least 2 weeks prior to start of therapy. All side effects must have resolved prior to start of OSI-774/Docetaxel.
- Patients must have adequate renal function as documented by a serum creatinine < 1.5 mg/dl or a calculated creatinine clearance of > 50 ml/min (see appendix for formula for calculating creatinine clearance).
- Patients must have adequate liver function as documented by serum bilirubin < ULN. AST must be < 2.5 x institutional upper limit of normal.
- Patients must have a pretreatment granulocyte count of >1500/mm3 and platelet count of >100 000/mm3.
- Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) may be included if they are neurologically stable and have been off steroids and anticonvulsants for at least 4 weeks. Because of the possibility of treatment related neurological toxicity it is difficult to evaluate for toxicity in the presence of symptomatic brain metastasis.
- All patients must give written informed consent.
- Able to take and retain oral medication.
- Patients of reproductive potential must agree to use effective contraceptive method while on treatment and for 3 months afterwards as the effects of these drugs on the unborn fetus are unknown.
- Patients on Coumadin should have their INR monitored at least once per week or more frequently depending on the investigators judgment. There have been some case reports of increased INR when Coumadin is co-administered with OSI-774/placebo.
Who cannot join
- May not have previously received docetaxel; OSI-774 or any prior EGFR targeted therapy.
- Females can not be pregnant or breastfeeding as the effects of these drugs on the unborn fetus are unknown. Documentation of a negative pregnancy test is required for all women of reproductive potential.
- Patients with symptomatic brain metastasis or still requiring steroids may not be included.
- Clinically significant ophthalmologic abnormalities will be excluded. This includes severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren's syndrome, severe exposure keratopathy, or other disorders that might increase the risk of corneal epithelial injury.
- A history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
- Pre-existing neuropathy > grade 2 may not participate
- No other prior malignancy is allowed for the phase II portion except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for over five years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: Phase I/II Study of Docetaxel and OSI-774 (Erlotinib) in Solid Tumor Patients With an Emphasis on NSCLC Using Molecular Correlates as Potential Markers of Response
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with docetaxel in treating patients with solid tumors and to see how well they work in treating patients with advanced non-small cell lung cancer. (Phase I portion of the study treating patients with any solid tumor was completed as of 12/01/2004)
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety and feasibility of two different schedules of erlotinib hydrochloride and docetaxel in patients with advanced solid tumors. (Phase I [completed as of 12/01/2004])
- Determine the response rate in patients with advanced non-small cell lung cancer treated with second-line docetaxel and erlotinib hydrochloride. (Phase II)
Secondary
- Compare the toxicity of two different schedules of erlotinib hydrochloride and docetaxel in these patients. (Phase I [completed as of 12/01/2004])
- Determine the maximum tolerated dose of two different schedules of erlotinib hydrochloride and docetaxel. (Phase I [completed as of 12/01/2004])
- Assess the overall survival and progression-free survival. (Phase II)
- Determine the frequency and severity of toxicities associated with this treatment regimen. (Phase II)
Tertiary
- Perform laboratory correlative studies on patient tissue and blood samples to investigate potential predictors of response.
OUTLINE: This is a phase I, dose-escalation study of erlotinib hydrochloride (phase I completed as of 12/01/2004) followed by a phase II, open-label study.
- Phase I (completed as of 12/01/2004): Patients will be assigned in alternating fashion to 1 of 2 treatment groups.
- Group I: Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16.
- Group II: Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16.
In both groups, treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.
In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.
Blood samples, buccal mucosal cells, and tumor tissue are obtained before and after treatment. Epidermal growth factor receptor (EGFR) expression and polymorphisms and p27 protein expression are assessed by immunohistochemistry. Immunofluorescence (by laser-scanning cytometry) is used to detect EGFR and p27.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
- Being tested
- docetaxel, erlotinib hydrochloride
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called Taxotere
Given IV
erlotinib hydrochlorideDrug
Also called OSI-774, Tarceva
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Group I (completed) | Experimental | Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. Receives: Drug: docetaxel; Drug: erlotinib hydrochloride |
| Phase I, Group II (completed) | Experimental | Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. Receives: Drug: docetaxel; Drug: erlotinib hydrochloride |
| Phase II | Experimental | Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. Receives: Drug: docetaxel; Drug: erlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Toxicity of Erlotinib Hydrochloride and Docetaxel as Measured by NCI CTC v3.0 on Day 8 of Course 1 and on Day 1 of Every Subsequent Course (Phase I [Completed as of 12/01/2004])
Measured: Up to 36 months
Response Rate (Phase II)
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Up to 36 months
Secondary outcomes (10)
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])
Measured: up to 36 months
Maximum Tolerated Dose of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])
Maximum tolerated dose (MTD) defined as the highest dose level at which no more than one patient experienced DLT when at least 6 patients were treated at that dose level and were assessable for toxicity, graded according to NCI CTCAE 2.0.
Measured: up to 36 months
Overall Survival (Phase II)
Measured: Up to 65 months
Progression-free Survival (Phase II)
Measured: Completion of study (up to 65 months)
Frequency and Severity of Toxicities (Phase II)
Treatment-related adverse events Grade ≥3 by NCI CTCAE 2.0.
Measured: Completion of study (up to 36 months)
Prognostic Significance of Epithelial Growth Factor Receptor (EGFR) Expression
Measured: Completion of study (up to 36 months)
Correlation of Baseline EGFR Levels With Clinical Outcome
Measured: Completion of study (up to 36 months)
Correlation of Basal Levels of p27 With Response Rate and Overall Survival
Measured: Completion of study (up to 36 months)
Correlation of Phospho-EGFR With Increased p27 and Clinical Outcome
Measured: Completion of study
Correlation of EGFR Polymorphisms With Treatment Response and Clinical Outcome
Measured: Completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startJul 2002
- Primary completionAug 2008
- Study completionAug 2012
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Genentech, Inc., Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- David R. Gandara, MD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390429
- Sponsor's protocol ID
- 273721
- Other IDs
- P30CA093373, UCDCC-128, UCDCC-200311717-5, AVENTIS-Z1001055, CDR0000505821
- Status last verified
- Nov 2018
- First submitted
- 18 Oct 2006
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Docetaxel and OSI-774 (Erlotinib) in Solid Tumor Patients With an Emphasis on NSCLC Using Molecular Correlates as Potential Markers of Response
- ClinicalTrials.gov ID
- NCT00390429
- Acronym / sponsor ID
- 273721
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Genentech, Inc., Aventis Pharmaceuticals
- Study start
- Jul 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Oct 2006 (estimated)
- Results
- Posted 26 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with docetaxel in treating patients with solid tumors and to see how well they work in treating patients with advanced non-small cell lung cancer. (Phase I portion of the study treating patients with any solid tumor was completed as of 12/01/2004)
Detailed description
OBJECTIVES:
Primary
- Determine the safety and feasibility of two different schedules of erlotinib hydrochloride and docetaxel in patients with advanced solid tumors. (Phase I [completed as of 12/01/2004])
- Determine the response rate in patients with advanced non-small cell lung cancer treated with second-line docetaxel and erlotinib hydrochloride. (Phase II)
Secondary
- Compare the toxicity of two different schedules of erlotinib hydrochloride and docetaxel in these patients. (Phase I [completed as of 12/01/2004])
- Determine the maximum tolerated dose of two different schedules of erlotinib hydrochloride and docetaxel. (Phase I [completed as of 12/01/2004])
- Assess the overall survival and progression-free survival. (Phase II)
- Determine the frequency and severity of toxicities associated with this treatment regimen. (Phase II)
Tertiary
- Perform laboratory correlative studies on patient tissue and blood samples to investigate potential predictors of response.
OUTLINE: This is a phase I, dose-escalation study of erlotinib hydrochloride (phase I completed as of 12/01/2004) followed by a phase II, open-label study.
- Phase I (completed as of 12/01/2004): Patients will be assigned in alternating fashion to 1 of 2 treatment groups.
- Group I: Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16.
- Group II: Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16.
In both groups, treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.
In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.
Blood samples, buccal mucosal cells, and tumor tissue are obtained before and after treatment. Epidermal growth factor receptor (EGFR) expression and polymorphisms and p27 protein expression are assessed by immunohistochemistry. Immunofluorescence (by laser-scanning cytometry) is used to detect EGFR and p27.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I, Group I (completed) | Experimental | Drug: docetaxel, Drug: erlotinib hydrochloridePatients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. |
| Phase I, Group II (completed) | Experimental | Drug: docetaxel, Drug: erlotinib hydrochloridePatients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. |
| Phase II | Experimental | Drug: docetaxel, Drug: erlotinib hydrochloridePatients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- For the phase II portion patients must have cytologically or histologically proven NSCLC. (Completed 12/1/04 - For the phase I portion of the study patients must have cytologically or histologically proven advanced solid tumors for which there is no standard therapy of curative intent).
- For the phase II portion patients must have disease that has progressed or recurred after treatment with platinum based therapy. Patients that have stable disease after front line platinum based therapy is also eligible.
- No more than 1 previous treatment for metastatic disease is allowed for the phase II portion. (Completed 12/1/04 - Any number of prior chemotherapy regimens for metastatic disease are allowed for the phase I portion).
- Patients must have measurable disease by RECIST criteria. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy. (Completed 12/1/04 - Patients with evaluable disease may be included in the phase I portion of the trial.
- Patients must be 18 years of age or older.
Key exclusion criteria (7 listed)
- May not have previously received docetaxel; OSI-774 or any prior EGFR targeted therapy.
- Females can not be pregnant or breastfeeding as the effects of these drugs on the unborn fetus are unknown. Documentation of a negative pregnancy test is required for all women of reproductive potential.
- Patients with symptomatic brain metastasis or still requiring steroids may not be included.
- Clinically significant ophthalmologic abnormalities will be excluded. This includes severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren's syndrome, severe exposure keratopathy, or other disorders that might increase the risk of corneal epithelial injury.
- A history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
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 |
|---|---|---|
| docetaxelAlso: TaxotereGiven IV | Drug | Phase I, Group I (completed), Phase I, Group II (completed), Phase II |
| erlotinib hydrochlorideAlso: OSI-774, TarcevaGiven orally | Drug | Phase I, Group I (completed), Phase I, Group II (completed), Phase II |
Primary outcome
Safety and Toxicity of Erlotinib Hydrochloride and Docetaxel as Measured by NCI CTC v3.0 on Day 8 of Course 1 and on Day 1 of Every Subsequent Course (Phase I [Completed as of 12/01/2004])
Time frame: Up to 36 months
Response Rate (Phase II)
Time frame: Up to 36 months
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
10 secondary outcomes
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])
Time frame: up to 36 months
Maximum Tolerated Dose of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])
Time frame: up to 36 months
Overall Survival (Phase II)
Time frame: Up to 65 months
Progression-free Survival (Phase II)
Time frame: Completion of study (up to 65 months)
Frequency and Severity of Toxicities (Phase II)
Time frame: Completion of study (up to 36 months)
Prognostic Significance of Epithelial Growth Factor Receptor (EGFR) Expression
Time frame: Completion of study (up to 36 months)
Correlation of Baseline EGFR Levels With Clinical Outcome
Time frame: Completion of study (up to 36 months)
Correlation of Basal Levels of p27 With Response Rate and Overall Survival
Time frame: Completion of study (up to 36 months)
Correlation of Phospho-EGFR With Increased p27 and Clinical Outcome
Time frame: Completion of study
Correlation of EGFR Polymorphisms With Treatment Response and Clinical Outcome
Time frame: Completion of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David R. Gandara, MD study chair
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing docetaxel and erlotinib hydrochloride in people with Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by University of California, Davis 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 16 inclusion and 7 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 6 Dec 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 26 Oct 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?
Safety and Toxicity of Erlotinib Hydrochloride and Docetaxel as Measured by NCI CTC v3.0 on Day 8 of Course 1 and on Day 1 of Every Subsequent Course (Phase I [Completed as of 12/01/2004]) (time frame: Up to 36 months). The study lists 2 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 6 Dec 2018.