Adult Anaplastic AstrocytomaPhase 1NCT00030498
Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction
A Phase 1 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma
- 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
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Jul 2007
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed solid tumor, including gliomas and the following epithelial malignancies:
- Non-small cell lung
- Mesothelioma
- Breast
- Head and neck
- Esophageal
Show all 63Show fewer
- Pancreatic
- Bladder
- Prostate
- Ovarian
- Anal
- Colorectal carcinoma
- Cervical carcinoma
- Hepatocellular carcinoma
- Metastatic or unresectable disease
- Standard curative or palliative therapy does not exist or is no longer effective
- Epidermal growth factor receptor (EGFR) positive
- Hepatic or renal dysfunction defined as one of the following:
- Direct bilirubin 1.0-7.0 mg/dL with any AST
- Albumin less than 2.5 g/dL
- Creatinine 2.5-5.0 mg/dL
- Brain metastases allowed provided patient is asymptomatic, previously treated, has stable disease for at least 2 months, and is not currently receiving steroid therapy
- Hormone receptor status:
- Not specified
- Male or female
- Performance status - ECOG 0-2
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- See Disease Characteristics
- No evidence of biliary obstruction
- See Disease Characteristics
- No evidence of renal obstruction
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No gastrointestinal tract disease that would preclude ability to take oral medications
- No requirement for IV alimentation
- No active peptic ulcer disease
- No prior corneal abnormalities (e.g., dry eye syndrome or Sjogren's syndrome)
- No prior congenital abnormality (e.g., Fuch's dystrophy)
- No prior abnormal slit-lamp exam using a vital dye (e.g., fluorescein or Bengal-Rose)
- No prior abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
- No other concurrent uncontrolled illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- At least 4 weeks since prior chemotherapy (6 weeks for melphalan or mitomycin)
- No prior nitrosoureas
- See Disease Characteristics
- No concurrent steroids
- At least 4 weeks since prior radiotherapy
- At least 4 weeks since prior major surgery
- No prior surgical procedures affecting absorption
- No prior EGFR-targeting therapies, including gefitinib or Imclone C-225
- At least 3 months since prior suramin
- More than 7 days since prior grapefruit juice
- More than 7 days since other prior CYP3A4 inhibitors
- No concurrent grapefruit juice
- No concurrent CYP3A4 inducers, substrates, or other inhibitors
- No concurrent medications known to affect hepatic or renal function, including antiseizure medication or nonsteroidal anti-inflammatory agents
- No concurrent combination anti-retroviral therapy for HIV-positive patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction
Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose of erlotinib in patients with solid tumors and hepatic or renal dysfunction.
II. Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to hepatic or renal dysfunction (albumin less than 2.5 g/dL, direct bilirubin less than 1.0 mg/dL, any AST, and creatinine normal vs direct bilirubin 1.0-7.0 mg/dL, any AST, and creatinine normal vs creatinine 2.5-5.0 mg/dL, albumin 2.5 g/dL or greater, AST less than 3 times upper limit of normal, and direct bilirubin less than 1.0 mg/dL).
Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 evaluable patients are treated at that dose.
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Ependymoblastoma
- Being tested
- erlotinib hydrochloride, laboratory biomarker analysis
- Medical subject headings
- Astrocytoma, Ependymoma, Oligodendroglioma, Neuroectodermal Tumors, Primitive, Glioblastoma, Gliosarcoma, Glioma, Carcinoma, Hepatocellular
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. Treatment continues 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.
Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities
Measured: Within the first 4 weeks treatment
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 startDec 2001
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Anaplastic AstrocytomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Antonius Miller, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030498
- Sponsor's protocol ID
- NCI-2012-01868
- Other IDs
- CALGB-60101, U10CA031946, CDR0000069170
- Status last verified
- Jan 2013
- First submitted
- 14 Feb 2002
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction
- ClinicalTrials.gov ID
- NCT00030498
- Acronym / sponsor ID
- NCI-2012-01868
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Ependymoblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2001
- Primary completion
- Jul 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.
Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
Detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose of erlotinib in patients with solid tumors and hepatic or renal dysfunction.
II. Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to hepatic or renal dysfunction (albumin less than 2.5 g/dL, direct bilirubin less than 1.0 mg/dL, any AST, and creatinine normal vs direct bilirubin 1.0-7.0 mg/dL, any AST, and creatinine normal vs creatinine 2.5-5.0 mg/dL, albumin 2.5 g/dL or greater, AST less than 3 times upper limit of normal, and direct bilirubin less than 1.0 mg/dL).
Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 evaluable patients are treated at that dose.
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. Treatment continues 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 (63 listed)
- Histologically confirmed solid tumor, including gliomas and the following epithelial malignancies:
- Metastatic or unresectable disease
- Standard curative or palliative therapy does not exist or is no longer effective
- Epidermal growth factor receptor (EGFR) positive
- Hepatic or renal dysfunction defined as one of the following:
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
Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities
Time frame: Within the first 4 weeks treatment
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 16 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.
Antonius Miller principal investigator
Cancer and Leukemia Group B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, 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 63 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 16 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 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.
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?
Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities (time frame: Within the first 4 weeks treatment). 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 16 Jan 2013.