Kidney CancerPhase 2OSI-774NCT00045487
Erlotinib in Treating Patients With Advanced Kidney Cancer
A Phase 2 study testing OSI-774 in people with Kidney Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- OSI-774
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to May 2008
- 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
- Patients must have histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma (RCC). Papillary RCC is permitted only if immunohistochemical evidence of strong (2-3+) EGFR expression.
- Disease that is recurrent or refractory to IL-2 or IFN-based therapy or new diagnosis in previously untreated patients who are not appropriate candidates to receive IL-2 -based treatment
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- Prior nephrectomy or resection of metastatic lesions permitted if full surgical recovery has occurred.
- Age > 18 years Because no dosing or adverse event data are currently available on the use of OSI-774 in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
- Life expectancy of at least 12 weeks
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- ECOG performance status of 0,1 or 2 or Karnofsky >60%
- Patients must have normal organ and marrow function as defined below:
- Hematopoietic
- Absolute neutrophil count at least ≥ 1,500/ul
- Platelet ≥ 100,000/uL
- Hemoglobin ≥ 9.0 g/dL, concomitant erythropoetin permitted Hepatic
- Total bilirubin within normal institutional limits b. AST (SGOT)/ALT (SGPT) ≤ 2.5 times institutional upper limit of normal (≤5 times ULN if liver metastases present) Renal
- Serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance > 60 mL/min/1.73m2 Calcium
- Corrected calcium < 12.0 mg/dl, concomitant hypocalcemic agents permitted
- Complete supportive and palliative care will continue to be provided to ameliorate signs and symptoms that were pre-existing or may arise while on study and which do not interfere with the objectives of the study. The use of erythropoietin and biphosphonates is permitted.
- Patients must have tumor blocks available for EGFR expression analysis to be eligible for treatment on this study.
Who cannot join
- History of active malignancy (other than RCC) in the past 3 years, other than nonmelanomatous skin cancer or in situ breast cancer or in situ cervical cancer.
- Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774.
- Prior treatment with EGFR targeting therapies.
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- Inability to understand the written informed consent document.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Major surgery, or significant traumatic injury occurring within 21 days prior to treatment.
- Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test).
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
- Pregnant women are excluded from this study because OSI-774 is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development. For this reason, women of childbearing potential and men must also agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
- Informed Consent - No study specific procedures will be performed without a written and signed informed consent document. Patients who do not demonstrate the ability to understand or the willingness to sign the written informed consent document are excluded from study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase II, Pharmacokinetic And Biologic Correlative Study of OSI-774, An EGFR Tyrosine Kinase Inhibitor, In Patients With Advanced Renal Cell Carcinoma
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer.
Read the detailed description
OBJECTIVES:
- Determine the antitumor activity of erlotinib in patients with advanced renal cell carcinoma.
- Evaluate the safety and tolerability, in terms of the toxicity profile, of this drug in these patients.
- Determine the biologic activity of this drug, in terms of early disease progression, progression-free survival, 12-month survival rate, and overall survival, in these patients.
- Determine the pharmacodynamics of this drug in these patients.
- Analyze the postreceptor effects of epidermal growth factor receptor-tyrosinase kinase inhibition by this drug on cell cycle, apoptosis, and angiogenesis in tumor biopsies from these patients.
- Correlate changes in biological measurements with indices of outcome in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 4 weeks for 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 8-10 months.
- Conditions
- Kidney Cancer
- Being tested
- OSI-774
- Keywords
- recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-774Drug
OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.
| Study group | Role | What they receive |
|---|---|---|
| OSI-774 | Experimental | Not described Receives: Drug: OSI-774 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Ani-tumor Activity After Taking OSI-774.
Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).
Measured: Disease progression or 52 weeks duration
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 startJun 2002
- Primary completionMay 2008
- Study completionMay 2008
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 Kidney CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anthony W. Tolcher, MD, Study chair, The University of Texas Health Science Center at San AntonioAlain Mita, MD, Principal investigator, Cedar Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045487
- Sponsor's protocol ID
- CDR0000256598
- Other IDs
- IDD 01-27, NCI-5410
- Acronym
- OSI-774
- Status last verified
- Dec 2013
- First submitted
- 6 Sep 2002
- Last updated
- 27 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Pharmacokinetic And Biologic Correlative Study of OSI-774, An EGFR Tyrosine Kinase Inhibitor, In Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00045487
- Acronym / sponsor ID
- OSI-774 / CDR0000256598
- Conditions
- Kidney Cancer
- Keywords
- recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2002
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 27 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer.
Detailed description
OBJECTIVES:
- Determine the antitumor activity of erlotinib in patients with advanced renal cell carcinoma.
- Evaluate the safety and tolerability, in terms of the toxicity profile, of this drug in these patients.
- Determine the biologic activity of this drug, in terms of early disease progression, progression-free survival, 12-month survival rate, and overall survival, in these patients.
- Determine the pharmacodynamics of this drug in these patients.
- Analyze the postreceptor effects of epidermal growth factor receptor-tyrosinase kinase inhibition by this drug on cell cycle, apoptosis, and angiogenesis in tumor biopsies from these patients.
- Correlate changes in biological measurements with indices of outcome in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 4 weeks for 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 8-10 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSI-774 | Experimental | Drug: OSI-774 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma (RCC). Papillary RCC is permitted only if immunohistochemical evidence of strong (2-3+) EGFR expression.
- Disease that is recurrent or refractory to IL-2 or IFN-based therapy or new diagnosis in previously untreated patients who are not appropriate candidates to receive IL-2 -based treatment
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- Prior nephrectomy or resection of metastatic lesions permitted if full surgical recovery has occurred.
- Age > 18 years Because no dosing or adverse event data are currently available on the use of OSI-774 in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
Key exclusion criteria (14 listed)
- History of active malignancy (other than RCC) in the past 3 years, other than nonmelanomatous skin cancer or in situ breast cancer or in situ cervical cancer.
- Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774.
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 |
|---|---|---|
| OSI-774OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. | Drug | OSI-774 |
Primary outcome
Number of Patients With Ani-tumor Activity After Taking OSI-774.
Time frame: Disease progression or 52 weeks duration
Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
- 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.
Anthony W. Tolcher, MD study chair
The University of Texas Health Science Center at San Antonio
Alain Mita, MD principal investigator
Cedar Sinai
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 OSI-774 in people with Kidney Cancer, run by The University of Texas Health Science Center at San Antonio 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 17 inclusion and 14 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 2014. 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 27 Jan 2014). 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?
Number of Patients With Ani-tumor Activity After Taking OSI-774. (time frame: Disease progression or 52 weeks duration). 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 2014.