Kidney NeoplasmsPhase 2NCT00226980
A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
A Phase 2 study testing Thalidomide and Capecitabine in people with Kidney Neoplasms, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Thalidomide and Capecitabine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jul 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:- Able to comprehend and sign an IRB approved Informed consent
- Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
- Male or female 18 years or older
- Willing to use contraception
- Pathologic diagnosis of renal cell carcinoma
- Bi-dimensionally measurable disease
- Evidence of disease progression prior to start of treatment
- Failed prior immunotherapy or unwilling/unable to receive prior immunotherapy
- Adequate hematologic data: ANC.1.5; platelets>100x10^9
- Adequate renal function: Creatinine clearance .50cc
- Adequate liver function: Alkaline phos <3XULN AST/ALT <3XULN T.Bili <1.5XULN
- ECOG performance status 0-1 Exclusion Criteria:- Known brain metastases.
- Peripheral neuropathy.
- Pregnant and/ or lactating female.
- Unable to take a baby aspirin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
The purpose of this study is to determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination.
- Conditions
- Kidney Neoplasms
- Being tested
- Thalidomide, Capecitabine
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
CapecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
Secondary outcomes (1)
Safety of the combination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionJul 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- Dr. Sandy Srinivas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226980
- Sponsor's protocol ID
- RENAL0001
- Other IDs
- NCT00226980, RENAL0001
- Status last verified
- Apr 2009
- First submitted
- 13 Sep 2005
- Last updated
- 14 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00226980
- Acronym / sponsor ID
- RENAL0001
- Conditions
- Kidney Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Oct 2002
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 27 Sep 2005 (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 determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Thalidomide | Drug | – |
| Capecitabine | Drug | – |
Primary outcome
Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
1 secondary outcome
Safety of the combination
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 14 Apr 2009.
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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.
Dr. Sandy Srinivas principal investigator
Stanford University
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 Thalidomide and Capecitabine in people with Kidney Neoplasms, run by Stanford University 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?
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 14 Apr 2009. 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?
Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.. 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 14 Apr 2009.