Carcinoma, Renal CellPhase 1/2NCT00522249
Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic RCC
A Phase 1/2 study testing Pegylated Alfa Interferon, sunitinib and erlotinib in people with Carcinoma, Renal Cell, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the combination of Pegylated Alfa Interferon (PEG-Intron), Sunitinib and Tarceva to see if this drug combination delays the disease progression of patients with metastatic Renal Cell Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Pegylated Alfa Interferon, sunitinib and erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jul 2008
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed metastatic or unresectable RCC. Patients must have a component of conventional clear cell renal carcinoma or papillary renal carcinoma.
- No more than three prior systemic therapies of any kind for RCC including: 1) Immunotherapy (Adjuvant vaccines, Interleukin-2, Interferon-α) 2) Chemotherapy 3) Molecular targeted agents (Nexavar [Sorafenib], Bevacizumab [Avastin]) 4) Investigational therapy
- Patients with their primary tumor in place who are appropriate surgical candidates should be strongly encouraged (but not required) to undergo nephrectomy.
- Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated.
- All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to registration. Patients must have recovered from surgery and/or radiotherapy toxicity prior to registration.
- At the time of enrollment, patients must have evidence of metastatic or unresectable disease.
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- Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry staining or every effort made to obtain samples.
- Karnofsky performance status > 70%.
- Echocardiogram ejection fraction of ≥ 45%
- Age >18.
- Must meet required initial laboratory values
Who cannot join
- Patients with true chromophobe, oncocytoma, collecting duct tumor and transitional cell carcinoma are NOT eligible.
- Patients who have received small molecule epithelial growth factor inhibitors (such as Irresa, Tarceva) are excluded.
- Patients who have had prior exposure to sunitinib are excluded.
- No ongoing hemoptysis, or cerebrovascular accident within 12 months, or peripheral vascular disease with claudication on less than 1 block, or history of clinically significant bleeding, because of the potential bleeding and/or clotting risk with this combination therapy.
- No deep venous thrombosis or pulmonary embolus within 12 months of randomization and no ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed.
- No evidence of current central nervous system (CNS) metastases. Any imaging abnormality indicative of CNS metastases will exclude the patient from the study.
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- No significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV) angina pectoris requiring nitrate therapy, or recent myocardial infarction (within the last 6 months).
- No active ischemia on electrocardiogram.
- No patients with uncontrolled hypertension (defined as blood pressure of > 160 mmHg systolic and/or > 90 mmHg diastolic on medication).
- - Any ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency) is not permitted. Topical and/or inhaled steroids are allowed.
- Patients with a pre-existing thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication are ineligible.
- No uncontrolled psychiatric disorder.
- Patients with delayed healing of wounds, ulcers, and/or bone fractures are not eligible.
- Patients with a 'currently active' second malignancy other than non-melanoma skin cancers are not eligible.
- Pregnant women are excluded (negative urine or serum pregnancy test required) because of the potential for teratogenic or abortifacient effects of therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine - Methodist Hospital
Houston, Texas, 77030
About this study
Official title: A Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic Renal Cell Carcinoma
The purpose of this study is to evaluate the combination of Pegylated Alfa Interferon (PEG-Intron), Sunitinib and Tarceva to see if this drug combination delays the disease progression of patients with metastatic Renal Cell Carcinoma. The first phase of this study will determine the best dose of Peg-Intron, Sunitinib and Tarceva when given in combination. The safety of giving these drugs in combination and response to treatment will also be examined.
Read the detailed description
Over 75% of RCCs are highly vascularized tumors that overexpress a number of growth factors, including VEGF, PDGF, and bFGF. In addition, RCC tumors overexpress the receptors for these peptides. These ligands and receptors may be involved in the autocrine stimulation of tumor cell growth, or in the paracrine stimulation of neovascular or stromal fibroblast growth that supports tumor expansion. Novel treatment that specifically interrupts these signaling pathways may have significant anti-tumor activity. When taken together, these data provide a rationale for investigation of a combination therapy with PEG-Intron, Sunitinib and Tarceva for clear cell and papillary RCC patients.
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Metastatic Renal Cell Carcinoma, RCC, M3thodist, Pegylated Alfa Interferon, Sunitinib, Tarceva, Peg IFN
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Alfa InterferonDrug
Also called Intron A, PEG Intron®, PEG-Intron Redipen®
Each patient will receive PEG-Intron administered subcutaneously one day per week of each 6 week cycle. The dose of PEG-Intron is determined based on the patient's weight and the dose level.
sunitinibDrug
Also called Sutent®
Patients will receive sunitinib orally as a single daily dose on Days 1-28 of each 42-day cycle. The dose will depend on the dose level.
erlotinibDrug
Also called Tarceva®
Tarceva will be administered orally, 1-42 of each 42 day cycle. Dose will depend on dose level. Supplied as 150-mg, 100-mg and 25-mg strengths, white film-coated tablets for administration.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One cycle of the combination therapy will be 42 days (6 weeks). All patients will receive PEG-Intron given subcutaneously on Day 1 each week. Patients will receive Sunitinib orally on Days 1-28 of each cycle. Patients will receive Tarceva orally on Days 1-42. Receives: Drug: Pegylated Alfa Interferon; Drug: sunitinib; Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression Objective response rate
Measured: every 6 wks
Secondary outcomes (1)
Overall survival
Measured: every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2008
- Study completionJul 2008
Why it stopped: PI decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Robert J Amato, DO, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522249
- Sponsor's protocol ID
- PAC IRB#0806-0132
- Other IDs
- RCC-06-101
- Status last verified
- Mar 2016
- First submitted
- 27 Aug 2007
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00522249
- Acronym / sponsor ID
- PAC IRB#0806-0132
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Metastatic Renal Cell Carcinoma, RCC, M3thodist, Pegylated Alfa Interferon, Sunitinib, Tarceva, Peg IFN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- May 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Aug 2007 (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 purpose of this study is to evaluate the combination of Pegylated Alfa Interferon (PEG-Intron), Sunitinib and Tarceva to see if this drug combination delays the disease progression of patients with metastatic Renal Cell Carcinoma. The first phase of this study will determine the best dose of Peg-Intron, Sunitinib and Tarceva when given in combination. The safety of giving these drugs in combination and response to treatment will also be examined.
Detailed description
Over 75% of RCCs are highly vascularized tumors that overexpress a number of growth factors, including VEGF, PDGF, and bFGF. In addition, RCC tumors overexpress the receptors for these peptides. These ligands and receptors may be involved in the autocrine stimulation of tumor cell growth, or in the paracrine stimulation of neovascular or stromal fibroblast growth that supports tumor expansion. Novel treatment that specifically interrupts these signaling pathways may have significant anti-tumor activity. When taken together, these data provide a rationale for investigation of a combination therapy with PEG-Intron, Sunitinib and Tarceva for clear cell and papillary RCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pegylated Alfa Interferon, Drug: sunitinib, Drug: erlotinibOne cycle of the combination therapy will be 42 days (6 weeks). All patients will receive PEG-Intron given subcutaneously on Day 1 each week. Patients will receive Sunitinib orally on Days 1-28 of each cycle. Patients will receive Tarceva orally on Days 1-42. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed metastatic or unresectable RCC. Patients must have a component of conventional clear cell renal carcinoma or papillary renal carcinoma.
- No more than three prior systemic therapies of any kind for RCC including: 1) Immunotherapy (Adjuvant vaccines, Interleukin-2, Interferon-α) 2) Chemotherapy 3) Molecular targeted agents (Nexavar [Sorafenib], Bevacizumab [Avastin]) 4) Investigational therapy
- Patients with their primary tumor in place who are appropriate surgical candidates should be strongly encouraged (but not required) to undergo nephrectomy.
- Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated.
- All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to registration. Patients must have recovered from surgery and/or radiotherapy toxicity prior to registration.
Key exclusion criteria (15 listed)
- Patients with true chromophobe, oncocytoma, collecting duct tumor and transitional cell carcinoma are NOT eligible.
- Patients who have received small molecule epithelial growth factor inhibitors (such as Irresa, Tarceva) are excluded.
- Patients who have had prior exposure to sunitinib are excluded.
- No ongoing hemoptysis, or cerebrovascular accident within 12 months, or peripheral vascular disease with claudication on less than 1 block, or history of clinically significant bleeding, because of the potential bleeding and/or clotting risk with this combination therapy.
- No deep venous thrombosis or pulmonary embolus within 12 months of randomization and no ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed.
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 |
|---|---|---|
| Pegylated Alfa InterferonAlso: Intron A, PEG Intron®, PEG-Intron Redipen®Each patient will receive PEG-Intron administered subcutaneously one day per week of each 6 week cycle. The dose of PEG-Intron is determined based on the patient's weight and the dose level. | Drug | 1 |
| sunitinibAlso: Sutent®Patients will receive sunitinib orally as a single daily dose on Days 1-28 of each 42-day cycle. The dose will depend on the dose level. | Drug | 1 |
| erlotinibAlso: Tarceva®Tarceva will be administered orally, 1-42 of each 42 day cycle. Dose will depend on dose level. Supplied as 150-mg, 100-mg and 25-mg strengths, white film-coated tablets for administration. | Drug | 1 |
Primary outcome
Time to progression Objective response rate
Time frame: every 6 wks
1 secondary outcome
Overall survival
Time frame: every 6 weeks
Results and safety
The study was stopped early (reason given: PI decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Robert J Amato, DO principal investigator
The Methodist Hospital Research Institute
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 Pegylated Alfa Interferon, sunitinib and erlotinib in people with Carcinoma, Renal Cell, run by The Methodist Hospital Research Institute 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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 17 Mar 2016. 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?
The study was stopped early (reason given: PI decision). Results are not available in the source record.
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?
Time to progression Objective response rate (time frame: every 6 wks). 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 17 Mar 2016.