Renal Cell CarcinomaPhase 2NCT00556049
Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
A Phase 2 study testing Gemcitabine and Sunitinib in people with Renal Cell Carcinoma and Neoplasm Metastases, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The purpose of this research study is to determine if the combination of sunitinib and gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied. Sunitinib is approved by the FDA for the treatment of renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Neoplasm Metastases
- What is being tested?
- Gemcitabine and Sunitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2007to Dec 2014
- 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
- Histologically proven metastatic renal cell carcinoma with any sarcomatoid histology or poor-risk features as defined by having 3 or more of the following characteristics:
- PS > 1, high serum lactate dehydrogenase
- low hemoglobin
- high "corrected" serum calcium
- 2 or more sites of metastatic disease
- time from initial diagnosis to evidence of metastatic disease 12 months or less
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- Evidence of unidimensional measurable disease based on RECIST criteria, with at least 1 measurable lesion
- Male or female, 18 years of age or older
- ECOG performance status of 0-2
- Patients with brain metastasis can only be included of they were treated 4 weeks or more prior to enrollment with whole brain radiation and the effects of treatment have resolved
- Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical procedure to NCI CTCAE version 3.0 grade of 1 or less
- Laboratory values as outlined in the protocol
- 2 weeks or more must have elapsed from the time of major surgery or radiation therapy prior to the day of registration
- No anticipated need for major surgical procedure during the course of the study
Who cannot join
- Prior treatment with sunitinib or gemcitabine
- More than one prior systemic therapy of any kind for renal cell carcinoma
- Uncontrolled high blood pressure
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, or symptomatic congestive heart failure
- Ejection fraction < 30%
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- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- NCT CTCAE grade 3 or higher hemorrhage within 4 weeks of starting treatment
- Significant vascular disease
- Current grade 3 or higher cardiac dysrhythmia or QT prolongation
- Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide
- Pregnancy or breastfeeding or inadequate contraception
- Evidence of bleeding diathesis or coagulopathy
- Serious, non-healing wound, ulcer or bone fracture
- Psychiatric illness/social situation that would limit compliance with study requirements
- Previous diagnosis of concurrent malignancy requiring active systemic therapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center'
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
The purpose of this research study is to determine if the combination of sunitinib and gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied. Sunitinib is approved by the FDA for the treatment of renal cell carcinoma. However, some patients' cancers do not respond to treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research has suggested that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic renal cell carcinoma.
Read the detailed description
- Participants will receive study treatment as an outpatient. Study treatment will be given in 3-week cycles.
- Sunitinib will be taken orally once per day for the first two weeks (days 1-14) of each treatment cycle.
- Gemcitabine will be given intravenously at the study clinic on days 1 and 8 of each treatment cycle.
- Before receiving sunitinib and gemcitabine on day 1 of each cycle the following will be performed: physical exam, performance status assessment and blood work. Before receiving gemcitabine on day 8 the following will be performed: physical exam, performance status assessment and blood work. Every 3 cycles a CT scan will be performed to measure the tumor.
- Conditions
- Renal Cell Carcinoma, Neoplasm Metastases
- Being tested
- Gemcitabine, Sunitinib
- Keywords
- mRCC, sunitinib, gemcitabine
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Intravenously on days 1 and 8 of each 21-day treatment cycle.
SunitinibDrug
Also called Sutent
Orally on days 1-14 of each 21-day treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sunitinib and gemcitabine Receives: Drug: Gemcitabine; Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.
Measured: Until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2013
- Study completionDec 2014
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 Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dror Michaelson, MD, Massachusetts General Hospital
- Investigators
- M. Dror Michaelson, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556049
- Sponsor's protocol ID
- 07-212
- Status last verified
- Mar 2016
- First submitted
- 7 Nov 2007
- Last updated
- 21 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00556049
- Acronym / sponsor ID
- 07-212
- Conditions
- Renal Cell Carcinoma, Neoplasm Metastases
- Keywords
- mRCC, sunitinib, gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Pfizer, Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute
- Study start
- Dec 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Posted 3 Apr 2015
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 research study is to determine if the combination of sunitinib and gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied. Sunitinib is approved by the FDA for the treatment of renal cell carcinoma. However, some patients' cancers do not respond to treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research has suggested that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic renal cell carcinoma.
Detailed description
- Participants will receive study treatment as an outpatient. Study treatment will be given in 3-week cycles.
- Sunitinib will be taken orally once per day for the first two weeks (days 1-14) of each treatment cycle.
- Gemcitabine will be given intravenously at the study clinic on days 1 and 8 of each treatment cycle.
- Before receiving sunitinib and gemcitabine on day 1 of each cycle the following will be performed: physical exam, performance status assessment and blood work. Before receiving gemcitabine on day 8 the following will be performed: physical exam, performance status assessment and blood work. Every 3 cycles a CT scan will be performed to measure the tumor.
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: Gemcitabine, Drug: SunitinibSunitinib and gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically proven metastatic renal cell carcinoma with any sarcomatoid histology or poor-risk features as defined by having 3 or more of the following characteristics:
- Evidence of unidimensional measurable disease based on RECIST criteria, with at least 1 measurable lesion
- Male or female, 18 years of age or older
- ECOG performance status of 0-2
- Patients with brain metastasis can only be included of they were treated 4 weeks or more prior to enrollment with whole brain radiation and the effects of treatment have resolved
Key exclusion criteria (16 listed)
- Prior treatment with sunitinib or gemcitabine
- More than one prior systemic therapy of any kind for renal cell carcinoma
- Uncontrolled high blood pressure
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, or symptomatic congestive heart failure
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 |
|---|---|---|
| GemcitabineAlso: GemzarIntravenously on days 1 and 8 of each 21-day treatment cycle. | Drug | 1 |
| SunitinibAlso: SutentOrally on days 1-14 of each 21-day treatment cycle | Drug | 1 |
Primary outcome
To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.
Time frame: Until disease progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
M. Dror Michaelson, MD, PhD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and Sunitinib in people with Renal Cell Carcinoma and Neoplasm Metastases, run by Massachusetts General Hospital at 3 sites 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 14 inclusion and 16 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 Apr 2015). 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?
To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy. (time frame: Until disease progression). 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 21 Apr 2016.