Advanced Malignant MesotheliomaPhase 2NCT00039182
Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
A Phase 2 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Advanced Malignant Mesothelioma and Epithelial Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma
- What is being tested?
- erlotinib hydrochloride and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Jun 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed malignant pleural mesothelioma
- Epithelial
- Sarcomatous
- Biphasic
- Measurable or nonmeasurable disease
- Not amenable to extrapleural pneumonectomy
Show all 38Show fewer
- No known CNS metastases
- Performance status - Zubrod 0-1
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor)
- Creatinine no greater than 2 times ULN
- No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
- No active peptic ulcer disease
- No intractable nausea or vomiting
- Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube
- No known history of the following:
- Dry eye syndrome
- Sjogren's syndrome
- Keratoconjunctivitis sicca
- Exposure keratopathy
- Fuch's dystrophy
- Other active disorders of the cornea
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No HIV-positive patients receiving combination antiretroviral therapy
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission
- No prior biologic therapy for this tumor
- No prior chemotherapy for this tumor
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- See Disease Characteristics
- At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies)
- Recovered from prior surgery
- No prior surgical procedures affecting absorption
- No prior investigational anticancer agents for this tumor
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.
II. Determine the response rate in patients with measurable disease treated with this drug.
III. Determine the frequency and severity of toxic effects of this drug in these patients.
IV. Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18 months.
- Conditions
- Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma
- Being tested
- erlotinib hydrochloride, laboratory biomarker analysis
- Medical subject headings
- Mesothelioma, Malignant, Solitary Fibrous Tumor, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Also called CP-358,774, erlotinib, OSI-774
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (erlotinib hydrochloride) | Experimental | Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Erlotinib hydrochloride will not be of further interest if the true one-year survival rate is 35% or less, but of considerable interest if 55% or more.
Measured: 1 year
RECIST response rate
Measured: Up to 3 years
Association between EGFR expression with survival and response
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2002
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant MesotheliomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Linda Garland, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039182
- Sponsor's protocol ID
- NCI-2012-02466
- Other IDs
- SWOG-S0218, U10CA032102, CDR0000069360
- Status last verified
- Jan 2013
- First submitted
- 6 Jun 2002
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT00039182
- Acronym / sponsor ID
- NCI-2012-02466
- Conditions
- Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2002
- Primary completion
- Jun 2007 (actual)
- First posted
- 27 Jan 2003 (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.
Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung
Detailed description
PRIMARY OBJECTIVES:
- Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.
II. Determine the response rate in patients with measurable disease treated with this drug.
III. Determine the frequency and severity of toxic effects of this drug in these patients.
IV. Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (erlotinib hydrochloride) | Experimental | Drug: erlotinib hydrochloride, Other: laboratory biomarker analysisPatients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (38 listed)
- Histologically confirmed malignant pleural mesothelioma
- Measurable or nonmeasurable disease
- Not amenable to extrapleural pneumonectomy
- No known CNS metastases
- Performance status - Zubrod 0-1
Key exclusion criteria (0 listed)
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 hydrochlorideAlso: CP-358,774, erlotinib, OSI-774Given orally | Drug | Treatment (erlotinib hydrochloride) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (erlotinib hydrochloride) |
Primary outcome
Overall survival rate
Time frame: 1 year
Erlotinib hydrochloride will not be of further interest if the true one-year survival rate is 35% or less, but of considerable interest if 55% or more.
RECIST response rate
Time frame: Up to 3 years
Association between EGFR expression with survival and response
Time frame: Up to 3 years
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 24 Jan 2013.
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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.
Linda Garland principal investigator
SWOG Cancer Research Network
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 hydrochloride and laboratory biomarker analysis in people with Advanced Malignant Mesothelioma and Epithelial Mesothelioma, run by National Cancer Institute (NCI) 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 38 inclusion and 0 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 24 Jan 2013. 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?
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?
Overall survival rate (time frame: 1 year). The study lists 3 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 24 Jan 2013.